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Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe CKD (Clarion-CKD)

Primary Purpose

Chronic Kidney Diseases

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
KBP-5074
Sponsored by
KBP Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Stage 3b/4 chronic kidney disease, Hypertension, Uncontrolled Hypertension, Blood pressure, Mineralocorticoid Receptor Antagonist, Randomized withdrawal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body mass index (BMI) must be ≥19 to <45 kg/m^2 at the Screening Visit

  • Participant must have uncontrolled hypertension defined as meeting both of the following criteria:

    • The participant has a resting seated trough cuff SBP ≥140 mm Hg at the Screening Visit (Visit 1), and at the start (Visit 2) and end (Visit 3) of the Run-In Period
    • The participant is taking 2 or more antihypertensive medications that have been titrated upward as tolerated to hypertension target doses per local SoC and have been stable (i.e., without any dose adjustments) from 4 weeks before the Screening Visit (Visit 1) through the end of the Run-In Period (Visit 3)
  • The participant must have Stage 3b (eGFR [EPI] ≥30 and ≤44 mL/min/1.73 m^2) or Stage 4 (eGFR [EPI] ≥15 and <30 mL/min/1.73 m^2) CKD.

Exclusion Criteria:

  • Participant has a resting seated trough cuff SBP ≥180 mm Hg at the Screening Visit (Visit 1) or at the start (Visit 2) or end (Visit 3) of the Run-In Period
  • Participant has a serum potassium level >4.8 mmol/L during the Screening or Run-In Periods
  • Participant has had a serum potassium level >5.6 mmol/L within 2 weeks before the Screening Visit (Visit 1)
  • Participant has been hospitalized for hyperkalemia within the 3 months before the Randomization Visit (Visit 3)
  • Participant was not compliant with taking placebo during the Run-in Period or participant was not compliant with background antihypertensive medications during the Run-in Period as assessed at the Randomization Visit (Visit 3)
  • Participant has taken an mineralocorticoid receptor antagonist (MRA), a potassium-sparing diuretic, or chronic potassium supplements during the 4 weeks before the Screening Visit (Visit 1)
  • Participant has taken potassium binders for the treatment of hyperkalemia during the 3 months before the Screening Visit (Visit 1)
  • Participant has taken a strong cytochrome P450 (CYP) CYP3A4 inducer or strong CYP3A4 inhibitor during the 7 days before the Randomization Visit (Visit 3)
  • Participant has taken a prohibited traditional Chinese medication during the 28 days prior to Screening Visit (Visit 1).
  • Participant was administered any other investigational product within 4 weeks or 5 half-lives (whichever is longer) prior to the Screening Visit (Visit 1).

Sites / Locations

  • G & L Research, LLCRecruiting
  • Nephrology Consultants, LLCRecruiting
  • Aventiv Research, IncRecruiting
  • Noble Clinical Research
  • National Heart InstituteRecruiting
  • Amicis Research Center (Valencia)
  • Amicis Research Center
  • Amicis Research CenterRecruiting
  • Renal Consultants Medical Group - Granada HillsRecruiting
  • United Clinical Research and InnovationsRecruiting
  • Solano Kidney CareRecruiting
  • Desert Cities Dialysis - AmethystRecruiting
  • Kidney and Hypertension CenterRecruiting
  • Davita Clinical Research-HartfordRecruiting
  • Synergy HealthcareRecruiting
  • Inpatient Research Clinic, LLCRecruiting
  • San Marcus Research Clinic, Inc.Recruiting
  • Homestead Associates in Research, IncRecruiting
  • Total Research GroupRecruiting
  • LCC Medical ResearchRecruiting
  • Oceane 7 Medical&Research Center, Inc.Recruiting
  • Allied Biomedical Research InstituteRecruiting
  • South Florida Research Phase I-Iv, Inc.Recruiting
  • New Generation Of Medical Research
  • Central Florida Heart CenterRecruiting
  • Omega Research Orlando, LLCRecruiting
  • Genesis Clinical ResearchRecruiting
  • Santos Research Center CORPRecruiting
  • Fides Clinical ResearchRecruiting
  • Southeastern Clinical Research Institute, LLCRecruiting
  • Columbus Associates LLCRecruiting
  • Central Georgia Kidney Specialists
  • Clinical Investigation Specialists, Inc.Recruiting
  • Massachusetts General Hospital (MGH) - Renal Associates ClinicRecruiting
  • InterMed ConsultantsRecruiting
  • Healthcare Research NetworkRecruiting
  • Clinical Research ConsultantsRecruiting
  • St. Louis Heart and Vascular, P.C. (SLHV) - Christian Hospital OfficeRecruiting
  • Healor Primary Care /CCT Research
  • DaVita Clinical Research (Nevada)Recruiting
  • Rutgers - New Jersey Medical School
  • Albert Einstein's College of MedicineRecruiting
  • Kidney Medical Associates, PLLCRecruiting
  • NYC Health + Hospitals / Queens - Diabetes Center of ExcellenceRecruiting
  • Mattoo & Bhat Medical Associates, PCRecruiting
  • Mountain Kidney & Hypertension Associates (MKHA), P.A - AshevilleRecruiting
  • Physicians East, PARecruiting
  • Eastern Nephrology Associates - JacksonvilleRecruiting
  • Eastern Nephrology Associates - New BernRecruiting
  • North Carolina Nephrology P.A.Recruiting
  • Brookview Hills Research Associates, LLCRecruiting
  • Providence Health Partners-Center for Clinical Research
  • Columbia Nephrology Associates, PARecruiting
  • Knoxville Kidney Center, PLLCRecruiting
  • Vanderbilt University School of Medicine (VUSM) - Vanderbilt Center for Kidney Disease (VCKD)
  • Davita Clinical Research El PasoRecruiting
  • Kidney Consultants of El Paso, P.A.Recruiting
  • DaVita Clinical Research HoustonRecruiting
  • Pioneer Research Solutions, Inc.Recruiting
  • Gamma Clinical Research Institute
  • Clinical Advancement Center, PLLCRecruiting
  • Urology San Antonio - North CentralRecruiting
  • DaVita Clinical ResearchRecruiting
  • Kidney Specialists of North Houston, PLLCRecruiting
  • Davita Norfolk SquareRecruiting
  • Dominion Medical Associates, Inc.Recruiting
  • MultiCare Institute for Research & Innovation - INW
  • Providence Medical Group Hospitalists - Internal Medicine
  • Clinical Investigation SpecialistsRecruiting
  • Milwaukee Nephrologists, SC (Rich)Recruiting
  • Concord Repatriation General Hospital - Nephrology
  • Renal ResearchRecruiting
  • Harvey Bay Hospital
  • Royal Adelaide Hospital
  • Monash Medical Centre
  • Austin HospitalRecruiting
  • Imelda Ziekenhuis
  • Hôpital Erasme
  • Universitair Ziekenhuis Gent
  • AZ Delta - Campus Rumbeke
  • UZ Brussel
  • UZ Brussel - Campus Jette - Nefrologie
  • CHU De Liège
  • Clinical Center University of Sarajevo
  • Univerzitetski klinicki centar Republike Srpske - Internal Medicine, NephrologyRecruiting
  • The University Hospital Foca
  • General Hospital Gradiska
  • General hospital Trebinje - Gastroenterology
  • Kantonalna bolnica Bihac - Internal Medicine, Nephrology
  • General Hospital Tesanj
  • University Clinical Hospital Mostar
  • University clinical center Sarajevo
  • University Clinical Center Tuzla
  • 5 th MHATRecruiting
  • Medical Center ExcelsiorRecruiting
  • UMHAT St. EkaterinaRecruiting
  • Comac Medical LtdRecruiting
  • Mhat Dr.Tota VenkovaRecruiting
  • Medical Center Hera EOOD
  • UMHAT KaspelaRecruiting
  • Medical Center "Teodora"Recruiting
  • DCC 22 - Sofia
  • Medical Center Hera EOODRecruiting
  • Medical Center ''Synexus Sofia'' EOODRecruiting
  • University Hospital of Active Treatment Prof. Stoyan KirkovichRecruiting
  • MHAT"Sv.Anna-Varna"ADRecruiting
  • Dr. Stephen S. Chow Medicine Professional CorporationRecruiting
  • Clinical Research Solutions IncorporatedRecruiting
  • MUHC Research Institute
  • Hopital du Sacré Cœur
  • Beijing Chao-Yang Hospital, Capital Medical University
  • Beijing An Zhen Hospital, Capital Medical UniversityRecruiting
  • Peking University First HospitalRecruiting
  • Beijing HospitalRecruiting
  • China-Japan Friendship HospitalRecruiting
  • The First Affiliated Hospital of Fujian Medical UniversityRecruiting
  • The First Affiliated Hospital of Xiamen UniversityRecruiting
  • Zhongshan Hospital Xiamen UniversityRecruiting
  • Guangdong Provincial People's HospitalRecruiting
  • Guangzhou First People's Hospital - Nephrology
  • The Third Affiliated Hospital, Sun Yat-sen UniversityRecruiting
  • The People's Hospital of Guangxi Zhuang Autonomous Region
  • The Affliated Hospital of Guizhou Medical University
  • The Second Hospital of Hebei Medical UniversityRecruiting
  • The First Affiliated Hospital of Zhengzhou University (East Compus)Recruiting
  • The Central Hospital of WuhanRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • The Third Xiangya Hospital of Central South UniversityRecruiting
  • Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical UniversityRecruiting
  • Wuxi People's HospitalRecruiting
  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechnologyRecruiting
  • General Hospital of Ningxia Medical University
  • First Hospital of Shanxi Medical University
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Shandong Provincial HospitalRecruiting
  • Yantai Yuhuangding Hospital(Base Cpmpus)Recruiting
  • Shanghai General HospitalRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • Sichuan Provincial People's Hospital- NephrologyRecruiting
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Zhejiang Hospital
  • Zhejiang Provincial People's Hospital
  • Jinhua Central HospitalRecruiting
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
  • The Southwest Hospital of AMURecruiting
  • Shanghai Sixth People's Hospital
  • Tianjin Medical University General Hospital
  • University Hospital Centre Zagreb
  • Opca bolnica VinkovciRecruiting
  • Klinicki Bolnicki Centar Rijeka - Ophthalmology
  • University Hospital Centre Osijek
  • General Hospital "Dr.Josip Bencevic"
  • University Hospital Center Split
  • Nemocnice Nove Mesto na Morave, p.o.
  • Nefrologie s.r.o.Recruiting
  • Nemocnice Trebic, p.o.
  • FN Kralovske Vinohrady
  • IKEMRecruiting
  • Alaron s.r.o.
  • LTD "High technology hospital MEDCENTER"
  • Ltd MarnecorRecruiting
  • Ministry of Defence of Georgia LEPL Giorgi Abramishvili Military HospitalRecruiting
  • JSC "Evex Hospitals'Recruiting
  • Aleksandre Aladashvili Clinic LLCRecruiting
  • "Pineo Medical Ecosystem"LTDRecruiting
  • JSC German Clinic
  • National Center of Urology Named after Laur ManagadzeRecruiting
  • Bokhua Memorial Cardiovascular CentreRecruiting
  • Emergency Cardiology Center named by acad. G. ChapidzeRecruiting
  • J.S.C."K.Eristavi National Center of Experimental and Clinical Surgery"
  • LTD Israel-Georgian Medical Research Clinic HelsicoreRecruiting
  • Nephrologisches Zentrum Villingen-SchwenningenRecruiting
  • Diabeteszentrum DO
  • DaVita Clinical Research Germany GmbHRecruiting
  • InnoDiab Forschung GmbH
  • Universitätsklinikum Mainz
  • Charité- Universitätsmedizin BerlinRecruiting
  • Charité - Universitätsmedizin BerlinRecruiting
  • Medizinische Hochschule HannoverRecruiting
  • Universitätsklinikum JenaRecruiting
  • Queen Mary Hospital - MedicineRecruiting
  • Tung Wah HospitalRecruiting
  • Coromed-Smo Kft.
  • IPR Hungary Kft.Recruiting
  • Trial Pharma Kft.
  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
  • Sonocor Egészségügyi Szolgáltató Kft.
  • TaNa Med KftRecruiting
  • Markhot Ferenc Oktatókórház és Rendelőintézet
  • BKS ResearchRecruiting
  • Kistarcsai Flor Ferenc KorhazRecruiting
  • DRC Gyógyszervizsgáló Központ Kft.Recruiting
  • Semmelweis EgyetemRecruiting
  • Jahn Ferenc Dél-Pesti Kórház és RendelőintézetRecruiting
  • Somogy Megyei Kaposi Mór Oktató Kórház
  • Rabin Medical Center
  • Western Galilee Hospital
  • Nazareth Hospital EMMS
  • The Barzilai Medical Center - Nephrology and Hypertension
  • Shaare Zedek Medical Center - Internal Medicine
  • Chungnam National University Hospital - Nephrology
  • National Health Insurance Service Ilsan Hospital - NephrologyRecruiting
  • Seoul National University Hospital - Nephrology
  • Gangnam Severance Hospital, Yonsei University Health System - Internal Medicine
  • Samsung Medical Center - Nephrology
  • The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
  • Saules seimos medicinos centrasRecruiting
  • Hospital Raja Perempuan Zainab IIRecruiting
  • Hospital Raja Permaisuri BainunRecruiting
  • Hospital Seri ManjungRecruiting
  • Hospital Kuala LumpurRecruiting
  • University Malaya Medical CentreRecruiting
  • Amsterdam UMC location Vumc
  • VU Medisch Centrum
  • Meander Medisch Centrum
  • Albert Schweitzer Ziekenhuis - Dordwijk
  • Amphia Ziekenhuis (Ignatius Hospital) - Locatie Molengracht
  • NZOZ Euromedica Sp. z o.o.
  • Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan RuxerRecruiting
  • Synexus Polska Sp. z o.o.
  • Synexus Polska Sp. z. o.o.Recruiting
  • SP ZOZ Centralny Szpital Kliniczny UM w Lodzi
  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
  • Synexus Polska Sp. z o.o.
  • Synexus Polska Sp. z o.o.
  • WroMedica I. Bielicka, A. Strzalkowska s.c.
  • Clinical Hospital Centre ZemunRecruiting
  • Clinical Centre Nis
  • Clinical Center Vojvodina
  • Military Medical Academy
  • Zvezdara University Medical CenterRecruiting
  • MSB General hospital - Clinical Research CenterRecruiting
  • Clinical Center Kragujevac
  • Iatros International
  • Charlotte Maxeke Johannesburg Hospital
  • Office of Gulam Hoosain VallyRecruiting
  • Tiervlei Trial Centre
  • Dr J.M. Engelbrecht Trial SiteRecruiting
  • Hospital público da MariñaRecruiting
  • Hospital Ribera PolusaRecruiting
  • Consorcio Hospital General Universitario de ValenciaRecruiting
  • FUNDACION PUIGVERT - Nephrology Department
  • Hospital del MarRecruiting
  • Hospital Quironsalud Barcelona
  • Hospital de La Santa Creu i Sant PauRecruiting
  • Hospital Universitario Virgen de las Nieves
  • Hospital Universitario Fundación Jiménez DíazRecruiting
  • Hospital Universitario Y Politécnico La FeRecruiting
  • Taichung Veterans General Hospital - Nephrology
  • National Taiwan University Hospital - Nephrology
  • China Medical University Hospital - Nephrology - TaichungRecruiting
  • Taipei Medical University - Shuang Ho Hospital - NephrologyRecruiting
  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - NephrologyRecruiting
  • Hacettepe Universitesi Hastaneleri (Hacettepe University Hos)
  • Akdeniz University Medical Faculty
  • Trakya University Medical Faculty
  • Bati Anadolu Universitesi (University of Western Anatolia) (UNWA) - BatiAnadolu Hastanesi Central Hospital - Izmir
  • Erciyes Universitesi Tip Fakultesi
  • Kocaeli University Research and Application Hospital
  • Mersin University Medical Faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

KBP-5074

Arm Description

All eligible participants will receive KBP-5074 matching placebo, for approximately 2 weeks, during the Open-label placebo Run-In period, then up to 24 weeks during the Double-blind treatment Period and during the Open-label treatment period, and thereafter for 4 weeks, during the randomized Double-blind withdrawal period.

All eligible participants will receive KBP-5074, for up to 24 weeks during the Double-blind treatment Period and during the Open-label treatment period. Thereafter, eligible participants will continue current dose of KBP-5074 at the end of the Open-label treatment period.

Outcomes

Primary Outcome Measures

Change in seated trough cuff SBP from baseline to Week 12
Efficacy of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP for KBP-5074 dose regimen compared to placebo, will be evaluated.
Change in seated trough cuff SBP from Week 48 to Week 52
Durability of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP for the KBP-5074 dose regimen compared to placebo, will be evaluated.

Secondary Outcome Measures

Change in seated trough cuff SBP from baseline to Week 24
Efficacy and durability of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP, will be evaluated.
Changes in seated trough cuff diastolic blood pressure (DBP) from baseline to Week 12 and Week 24
Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP, will be evaluated.
Changes in seated trough cuff SBP and DBP from baseline to Week 48
Effect of KBP-5074 on SBP and DBP by assessing change in seated trough cuff SBP and DBP, will be evaluated.
Changes in urinary albumin: creatinine ratio (UACR) from baseline to Week 12 and Week 24 for participants with UACR ≥30 mg/g at baseline
Effect of KBP-5074 on UACR by assessing changes in UACR for participants with UACR ≥30 mg/g at baseline, will be evaluated.
Percentage changes in UACR from baseline to Week 12 and Week 24 for participants with UACR ≥30 mg/g at baseline
Effect of KBP-5074 on UACR by assessing percentage changes in UACR for participants with UACR ≥30 mg/g at baseline, will be evaluated.
Changes in UACR from baseline to Week 12, Week 24, and Week 48
Effect of KBP-5074 on UACR by assessing changes in UACR for participants with macroalbuminuria (defined as UACR ≥300 mg/g) and microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, will be evaluated.
Percentage changes in UACR from baseline to Week 12, Week 24, and Week 48
Effect of KBP-5074 on UACR by assessing percentage changes in UACR for participants with macroalbuminuria (defined as UACR ≥300 mg/g) and microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, will be evaluated.
Change in seated trough cuff DBP from Week 48 to Week 52
Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP, will be evaluated.
Change in UACR from Week 48 to Week 52
Effect of KBP-5074 on UACR by assessing changes in UACR for participants with UACR ≥30 mg/g, macroalbuminuria (defined as UACR ≥300 mg/g) and microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, will be evaluated.
Percentage change in UACR from Week 48 to Week 52
Effect of KBP-5074 on UACR by assessing percentage changes in UACR for participants with UACR ≥30 mg/g, macroalbuminuria (defined as UACR ≥300 mg/g) and microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, will be evaluated.
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
The safety and tolerability of KBP-5074,will be evaluated.

Full Information

First Posted
July 7, 2021
Last Updated
September 1, 2023
Sponsor
KBP Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT04968184
Brief Title
Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe CKD
Acronym
Clarion-CKD
Official Title
A Phase 3 Randomized Double-Blind Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of KBP-5074 Mineralocorticoid Receptor Antagonist in Subjects With Uncontrolled Hypertension and Moderate or Severe (Stage 3b/4) CKD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2021 (Actual)
Primary Completion Date
September 15, 2024 (Anticipated)
Study Completion Date
January 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KBP Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This Phase 3, randomized, Double-blind, placebo-controlled, 2-arm, parallel-group, multicenter study with randomized withdrawal will evaluate the efficacy, safety, and durability of KBP-5074 in adult participants who have stage 3b/4 chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula [eGFR {EPI}] ≥15 to ≤44 mL/min/1.73 m^2) and uncontrolled hypertension (systolic blood pressure (SBP) ≥140 and <180 mm Hg and taking 2 or more antihypertensive medications.
Detailed Description
Participants in this study will be recruited, screened, and enrolled at approximately 140 study sites globally. The study will consist of the following periods: Pretreatment Phase: This will include prescreening assessment and screening period of up to 4 weeks and 2-week Open-label placebo Run-In period. A 24-week Double-blind Treatment Period (Randomization to Week 24) will include: An initial 12-week (Randomization to Week 12) and second 12-week (Week 12 to Week 24) treatment period and a second 12-week treatment period (Week 12 to Week 24), during both the periods study drug will be titrated. A 24-week Open-label Treatment Period (Week 24 to Week 48) during which eligible participants will receive Open-label KBP-5074. A 4-week Randomized Double-blind Withdrawal Period (Week 48 to Week 52) during which eligible participants will be randomized to continue their current KBP-5074 dose at the end of Open-label treatment or receive matching placebo for 4 weeks. A 4-week post-treatment Follow-Up Period (Week 52 to Week 56). During, 24-week Double-blind Treatment Period, 24-week Open-label Treatment Period, and at 4-week Randomized Double-blind Withdrawal Period, the background antihypertensive medications change may or may not be allowed. At Double-blind Treatment Period, eligible participants will be randomly assigned in a 1:1 ratio to KBP-5074 0.25 mg or matching placebo once daily (QD). At the Randomized Double-blind Withdrawal Period, participants who meet the randomized withdrawal criteria will be randomly assigned in a 1:1 ratio to continue their current KBP-5074 dose at the end of the Open-label Treatment Period or matching placebo QD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Stage 3b/4 chronic kidney disease, Hypertension, Uncontrolled Hypertension, Blood pressure, Mineralocorticoid Receptor Antagonist, Randomized withdrawal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All individuals directly involved in the conduct of the study, including participants, Investigators, site staff, clinical research organization (CRO) personnel, and Sponsor study personnel, will remain blinded to treatment assignments until all participants have completed the Week 56 end of study (EOS) Visit (Visit 17) and the database locked in preparation.
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
All eligible participants will receive KBP-5074 matching placebo, for approximately 2 weeks, during the Open-label placebo Run-In period, then up to 24 weeks during the Double-blind treatment Period and during the Open-label treatment period, and thereafter for 4 weeks, during the randomized Double-blind withdrawal period.
Arm Title
KBP-5074
Arm Type
Experimental
Arm Description
All eligible participants will receive KBP-5074, for up to 24 weeks during the Double-blind treatment Period and during the Open-label treatment period. Thereafter, eligible participants will continue current dose of KBP-5074 at the end of the Open-label treatment period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will orally receive placebo matching to KBP-5074 tablets QD.
Intervention Type
Drug
Intervention Name(s)
KBP-5074
Intervention Description
Participants will orally receive KBP-5074 tablets, from 0.25 mg to a maximum dose of 0.5-mg QD.
Primary Outcome Measure Information:
Title
Change in seated trough cuff SBP from baseline to Week 12
Description
Efficacy of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP for KBP-5074 dose regimen compared to placebo, will be evaluated.
Time Frame
From baseline to Week 12
Title
Change in seated trough cuff SBP from Week 48 to Week 52
Description
Durability of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP for the KBP-5074 dose regimen compared to placebo, will be evaluated.
Time Frame
Week 48 to Week 52
Secondary Outcome Measure Information:
Title
Change in seated trough cuff SBP from baseline to Week 24
Description
Efficacy and durability of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP, will be evaluated.
Time Frame
From baseline to Week 24
Title
Changes in seated trough cuff diastolic blood pressure (DBP) from baseline to Week 12 and Week 24
Description
Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP, will be evaluated.
Time Frame
From baseline to Week 12 and Week 24
Title
Changes in seated trough cuff SBP and DBP from baseline to Week 48
Description
Effect of KBP-5074 on SBP and DBP by assessing change in seated trough cuff SBP and DBP, will be evaluated.
Time Frame
From baseline to Week 48
Title
Changes in urinary albumin: creatinine ratio (UACR) from baseline to Week 12 and Week 24 for participants with UACR ≥30 mg/g at baseline
Description
Effect of KBP-5074 on UACR by assessing changes in UACR for participants with UACR ≥30 mg/g at baseline, will be evaluated.
Time Frame
From baseline to Week 12 and Week 24
Title
Percentage changes in UACR from baseline to Week 12 and Week 24 for participants with UACR ≥30 mg/g at baseline
Description
Effect of KBP-5074 on UACR by assessing percentage changes in UACR for participants with UACR ≥30 mg/g at baseline, will be evaluated.
Time Frame
From baseline to Week 12 and Week 24
Title
Changes in UACR from baseline to Week 12, Week 24, and Week 48
Description
Effect of KBP-5074 on UACR by assessing changes in UACR for participants with macroalbuminuria (defined as UACR ≥300 mg/g) and microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, will be evaluated.
Time Frame
From baseline to Week 12, Week 24, and Week 48
Title
Percentage changes in UACR from baseline to Week 12, Week 24, and Week 48
Description
Effect of KBP-5074 on UACR by assessing percentage changes in UACR for participants with macroalbuminuria (defined as UACR ≥300 mg/g) and microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, will be evaluated.
Time Frame
From baseline to Week 12, Week 24, and Week 48
Title
Change in seated trough cuff DBP from Week 48 to Week 52
Description
Effect of KBP-5074 on DBP by assessing change in seated trough cuff DBP, will be evaluated.
Time Frame
Week 48 to Week 52
Title
Change in UACR from Week 48 to Week 52
Description
Effect of KBP-5074 on UACR by assessing changes in UACR for participants with UACR ≥30 mg/g, macroalbuminuria (defined as UACR ≥300 mg/g) and microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, will be evaluated.
Time Frame
Week 48 to Week 52
Title
Percentage change in UACR from Week 48 to Week 52
Description
Effect of KBP-5074 on UACR by assessing percentage changes in UACR for participants with UACR ≥30 mg/g, macroalbuminuria (defined as UACR ≥300 mg/g) and microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline, will be evaluated.
Time Frame
Week 48 to Week 52
Title
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Description
The safety and tolerability of KBP-5074,will be evaluated.
Time Frame
Screening (Week -6 to -2) until EOS (Week 56) or Unscheduled visit or end of treatment or early termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body mass index (BMI) must be ≥19 to <45 kg/m^2 at the Screening Visit Participant must have uncontrolled hypertension defined as meeting both of the following criteria: The participant has a resting seated trough cuff SBP ≥140 mm Hg at the Screening Visit (Visit 1), and at the start (Visit 2) and end (Visit 3) of the Run-In Period The participant is taking 2 or more antihypertensive medications that have been titrated upward as tolerated to hypertension target doses per local SoC and have been stable (i.e., without any dose adjustments) from 4 weeks before the Screening Visit (Visit 1) through the end of the Run-In Period (Visit 3) The participant must have Stage 3b (eGFR [EPI] ≥30 and ≤44 mL/min/1.73 m^2) or Stage 4 (eGFR [EPI] ≥15 and <30 mL/min/1.73 m^2) CKD. Exclusion Criteria: Participant has a resting seated trough cuff SBP ≥180 mm Hg at the Screening Visit (Visit 1) or at the start (Visit 2) or end (Visit 3) of the Run-In Period Participant has a serum potassium level >4.8 mmol/L during the Screening or Run-In Periods Participant has had a serum potassium level >5.6 mmol/L within 2 weeks before the Screening Visit (Visit 1) Participant has been hospitalized for hyperkalemia within the 3 months before the Randomization Visit (Visit 3) Participant was not compliant with taking placebo during the Run-in Period or participant was not compliant with background antihypertensive medications during the Run-in Period as assessed at the Randomization Visit (Visit 3) Participant has taken an mineralocorticoid receptor antagonist (MRA), a potassium-sparing diuretic, or chronic potassium supplements during the 4 weeks before the Screening Visit (Visit 1) Participant has taken potassium binders for the treatment of hyperkalemia during the 3 months before the Screening Visit (Visit 1) Participant has taken a strong cytochrome P450 (CYP) CYP3A4 inducer or strong CYP3A4 inhibitor during the 7 days before the Randomization Visit (Visit 3) Participant has taken a prohibited traditional Chinese medication during the 28 days prior to Screening Visit (Visit 1). Participant was administered any other investigational product within 4 weeks or 5 half-lives (whichever is longer) prior to the Screening Visit (Visit 1).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KBP Biosciences Clinical Trials Contact
Phone
1 (609) 874-0416
Email
kbp5074clarion-ckd@kbpbiosciences.com
Facility Information:
Facility Name
G & L Research, LLC
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
Individual Site Status
Recruiting
Facility Name
Nephrology Consultants, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Individual Site Status
Recruiting
Facility Name
Aventiv Research, Inc
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Individual Site Status
Recruiting
Facility Name
Noble Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Suspended
Facility Name
National Heart Institute
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211-2285
Country
United States
Individual Site Status
Recruiting
Facility Name
Amicis Research Center (Valencia)
City
Granada Hills
State/Province
California
ZIP/Postal Code
91324
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Amicis Research Center
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Amicis Research Center
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Name
Renal Consultants Medical Group - Granada Hills
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Individual Site Status
Recruiting
Facility Name
United Clinical Research and Innovations
City
S. Gate
State/Province
California
ZIP/Postal Code
90280
Country
United States
Individual Site Status
Recruiting
Facility Name
Solano Kidney Care
City
Vacaville
State/Province
California
ZIP/Postal Code
95687-3557
Country
United States
Individual Site Status
Recruiting
Facility Name
Desert Cities Dialysis - Amethyst
City
Victorville
State/Province
California
ZIP/Postal Code
92392
Country
United States
Individual Site Status
Recruiting
Facility Name
Kidney and Hypertension Center
City
Victorville
State/Province
California
ZIP/Postal Code
92395
Country
United States
Individual Site Status
Recruiting
Facility Name
Davita Clinical Research-Hartford
City
Bloomfield
State/Province
Connecticut
ZIP/Postal Code
06002
Country
United States
Individual Site Status
Recruiting
Facility Name
Synergy Healthcare
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Individual Site Status
Recruiting
Facility Name
Inpatient Research Clinic, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
San Marcus Research Clinic, Inc.
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014-5602
Country
United States
Individual Site Status
Recruiting
Facility Name
Homestead Associates in Research, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33032-8225
Country
United States
Individual Site Status
Recruiting
Facility Name
Total Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33126-3422
Country
United States
Individual Site Status
Recruiting
Facility Name
LCC Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
Oceane 7 Medical&Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Recruiting
Facility Name
Allied Biomedical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
South Florida Research Phase I-Iv, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Recruiting
Facility Name
New Generation Of Medical Research
City
Naples
State/Province
Florida
ZIP/Postal Code
34104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Central Florida Heart Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Individual Site Status
Recruiting
Facility Name
Omega Research Orlando, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Individual Site Status
Recruiting
Facility Name
Genesis Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Name
Santos Research Center CORP
City
Tampa
State/Province
Florida
ZIP/Postal Code
33604
Country
United States
Individual Site Status
Recruiting
Facility Name
Fides Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Name
Southeastern Clinical Research Institute, LLC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904-3605
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbus Associates LLC
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Name
Central Georgia Kidney Specialists
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201-6863
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Investigation Specialists, Inc.
City
Gurney
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital (MGH) - Renal Associates Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
InterMed Consultants
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435-2129
Country
United States
Individual Site Status
Recruiting
Facility Name
Healthcare Research Network
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Consultants
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111-5964
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Louis Heart and Vascular, P.C. (SLHV) - Christian Hospital Office
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136-6111
Country
United States
Individual Site Status
Recruiting
Facility Name
Healor Primary Care /CCT Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102-1682
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DaVita Clinical Research (Nevada)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers - New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103-2425
Country
United States
Individual Site Status
Suspended
Facility Name
Albert Einstein's College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461-1900
Country
United States
Individual Site Status
Recruiting
Facility Name
Kidney Medical Associates, PLLC
City
Bronx
State/Province
New York
ZIP/Postal Code
10461-2710
Country
United States
Individual Site Status
Recruiting
Facility Name
NYC Health + Hospitals / Queens - Diabetes Center of Excellence
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Individual Site Status
Recruiting
Facility Name
Mattoo & Bhat Medical Associates, PC
City
Ridgewood
State/Province
New York
ZIP/Postal Code
11385
Country
United States
Individual Site Status
Recruiting
Facility Name
Mountain Kidney & Hypertension Associates (MKHA), P.A - Asheville
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801-4104
Country
United States
Individual Site Status
Recruiting
Facility Name
Physicians East, PA
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Name
Eastern Nephrology Associates - Jacksonville
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Individual Site Status
Recruiting
Facility Name
Eastern Nephrology Associates - New Bern
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562-5200
Country
United States
Individual Site Status
Recruiting
Facility Name
North Carolina Nephrology P.A.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609-7511
Country
United States
Individual Site Status
Recruiting
Facility Name
Brookview Hills Research Associates, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103-7108
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Health Partners-Center for Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Individual Site Status
Suspended
Facility Name
Columbia Nephrology Associates, PA
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Recruiting
Facility Name
Knoxville Kidney Center, PLLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923-3624
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University School of Medicine (VUSM) - Vanderbilt Center for Kidney Disease (VCKD)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2372
Country
United States
Individual Site Status
Suspended
Facility Name
Davita Clinical Research El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States
Individual Site Status
Recruiting
Facility Name
Kidney Consultants of El Paso, P.A.
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Individual Site Status
Recruiting
Facility Name
DaVita Clinical Research Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Individual Site Status
Recruiting
Facility Name
Gamma Clinical Research Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212-4738
Country
United States
Individual Site Status
Recruiting
Facility Name
Urology San Antonio - North Central
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
DaVita Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States
Individual Site Status
Recruiting
Facility Name
Kidney Specialists of North Houston, PLLC
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Individual Site Status
Recruiting
Facility Name
Davita Norfolk Square
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
Dominion Medical Associates, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Name
MultiCare Institute for Research & Innovation - INW
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202-1334
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Medical Group Hospitalists - Internal Medicine
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204-2307
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Clinical Investigation Specialists
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States
Individual Site Status
Recruiting
Facility Name
Milwaukee Nephrologists, SC (Rich)
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Concord Repatriation General Hospital - Nephrology
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2137
Country
Australia
Individual Site Status
Suspended
Facility Name
Renal Research
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Individual Site Status
Recruiting
Facility Name
Harvey Bay Hospital
City
Harvey Bay
State/Province
Queensland
ZIP/Postal Code
4655
Country
Australia
Individual Site Status
Suspended
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Suspended
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Imelda Ziekenhuis
City
Bonheiden
State/Province
Antwerpen
ZIP/Postal Code
2820
Country
Belgium
Individual Site Status
Suspended
Facility Name
Hôpital Erasme
City
Brussels
State/Province
Brussels Capital Region
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Suspended
Facility Name
Universitair Ziekenhuis Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Suspended
Facility Name
AZ Delta - Campus Rumbeke
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Suspended
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Suspended
Facility Name
UZ Brussel - Campus Jette - Nefrologie
City
Bruxelles
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Suspended
Facility Name
CHU De Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Suspended
Facility Name
Clinical Center University of Sarajevo
City
Sarajevo
State/Province
Kanton Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Individual Site Status
Suspended
Facility Name
Univerzitetski klinicki centar Republike Srpske - Internal Medicine, Nephrology
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Name
The University Hospital Foca
City
Foca
State/Province
Republika Srpska
ZIP/Postal Code
73300
Country
Bosnia and Herzegovina
Individual Site Status
Not yet recruiting
Facility Name
General Hospital Gradiska
City
Gradiska
State/Province
Republika Srpska
ZIP/Postal Code
78400
Country
Bosnia and Herzegovina
Individual Site Status
Not yet recruiting
Facility Name
General hospital Trebinje - Gastroenterology
City
Trebinje
State/Province
Republika Srpska
ZIP/Postal Code
89101
Country
Bosnia and Herzegovina
Individual Site Status
Not yet recruiting
Facility Name
Kantonalna bolnica Bihac - Internal Medicine, Nephrology
City
Bihać
State/Province
Unsko-sanski Kanton
ZIP/Postal Code
77000
Country
Bosnia and Herzegovina
Individual Site Status
Suspended
Facility Name
General Hospital Tesanj
City
Tešanj
State/Province
Zeničko-dobojski Kanton
ZIP/Postal Code
72460
Country
Bosnia and Herzegovina
Individual Site Status
Not yet recruiting
Facility Name
University Clinical Hospital Mostar
City
Mostar
ZIP/Postal Code
88000
Country
Bosnia and Herzegovina
Individual Site Status
Not yet recruiting
Facility Name
University clinical center Sarajevo
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Individual Site Status
Not yet recruiting
Facility Name
University Clinical Center Tuzla
City
Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Individual Site Status
Not yet recruiting
Facility Name
5 th MHAT
City
Sofia
State/Province
Sofia-Grad
ZIP/Postal Code
1233
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Excelsior
City
Sofia
State/Province
Sofia-Grad
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT St. Ekaterina
City
Sofia
State/Province
Sofia-Grad
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Comac Medical Ltd
City
Sofia
State/Province
Sofia-Grad
ZIP/Postal Code
1612
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Mhat Dr.Tota Venkova
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Hera EOOD
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
UMHAT Kaspela
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center "Teodora"
City
Ruse
ZIP/Postal Code
7012
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
DCC 22 - Sofia
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Medical Center Hera EOOD
City
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center ''Synexus Sofia'' EOOD
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University Hospital of Active Treatment Prof. Stoyan Kirkovich
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MHAT"Sv.Anna-Varna"AD
City
Varna
ZIP/Postal Code
9002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Dr. Stephen S. Chow Medicine Professional Corporation
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 5T2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinical Research Solutions Incorporated
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2T 0C1
Country
Canada
Individual Site Status
Recruiting
Facility Name
MUHC Research Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3S9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Hopital du Sacré Cœur
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Individual Site Status
Suspended
Facility Name
Beijing Chao-Yang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Beijing An Zhen Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Individual Site Status
Recruiting
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Guangzhou First People's Hospital - Nephrology
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Third Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Affliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550004
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
50004
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Zhengzhou University (East Compus)
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Name
The Central Hospital of Wuhan
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
City
Baotou
State/Province
Nei Mongol (mn)
Country
China
Individual Site Status
Recruiting
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Not yet recruiting
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shaanxi
ZIP/Postal Code
30001
Country
China
Individual Site Status
Suspended
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Yantai Yuhuangding Hospital(Base Cpmpus)
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Sichuan Provincial People's Hospital- Nephrology
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Zhejiang Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Jinhua Central Hospital
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
321000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
The Southwest Hospital of AMU
City
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Not yet recruiting
Facility Name
University Hospital Centre Zagreb
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Name
Opca bolnica Vinkovci
City
Vinkovci
State/Province
Osjecko-baranjska Županija
ZIP/Postal Code
32100
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Klinicki Bolnicki Centar Rijeka - Ophthalmology
City
Rijeka
State/Province
Primorsko-goranska Županija
ZIP/Postal Code
51000
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Name
University Hospital Centre Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Name
General Hospital "Dr.Josip Bencevic"
City
Slavonski Brod
ZIP/Postal Code
35000
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Name
University Hospital Center Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Name
Nemocnice Nove Mesto na Morave, p.o.
City
Nove Mesto na Morave
State/Province
Jihlava
ZIP/Postal Code
592 31
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Nefrologie s.r.o.
City
Praha
State/Province
Praha 4
ZIP/Postal Code
149 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Nemocnice Trebic, p.o.
City
Trebic
State/Province
Třebíč
ZIP/Postal Code
674 01
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
FN Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
IKEM
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Alaron s.r.o.
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
LTD "High technology hospital MEDCENTER"
City
Batumi
State/Province
Ajaria
ZIP/Postal Code
6000
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
Ltd Marnecor
City
Marneuli
State/Province
Kvemo Kartli
ZIP/Postal Code
3000
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Ministry of Defence of Georgia LEPL Giorgi Abramishvili Military Hospital
City
Gori
State/Province
Shida Kartli
ZIP/Postal Code
1400
Country
Georgia
Individual Site Status
Recruiting
Facility Name
JSC "Evex Hospitals'
City
Batumi
ZIP/Postal Code
6010
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Aleksandre Aladashvili Clinic LLC
City
Tbilisi
ZIP/Postal Code
0102
Country
Georgia
Individual Site Status
Recruiting
Facility Name
"Pineo Medical Ecosystem"LTD
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Individual Site Status
Recruiting
Facility Name
JSC German Clinic
City
Tbilisi
ZIP/Postal Code
0119
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
National Center of Urology Named after Laur Managadze
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Bokhua Memorial Cardiovascular Centre
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Emergency Cardiology Center named by acad. G. Chapidze
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
J.S.C."K.Eristavi National Center of Experimental and Clinical Surgery"
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
LTD Israel-Georgian Medical Research Clinic Helsicore
City
Tbilisi
ZIP/Postal Code
112
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Nephrologisches Zentrum Villingen-Schwenningen
City
Villingen-Schwenningen
State/Province
Baden-Württemberg
ZIP/Postal Code
78052
Country
Germany
Individual Site Status
Recruiting
Facility Name
Diabeteszentrum DO
City
Dortmund
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44137
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
DaVita Clinical Research Germany GmbH
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Name
InnoDiab Forschung GmbH
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Individual Site Status
Suspended
Facility Name
Universitätsklinikum Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Charité- Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Name
Queen Mary Hospital - Medicine
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Tung Wah Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Coromed-Smo Kft.
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
IPR Hungary Kft.
City
Miskolc
State/Province
Borsod-Abaúj-Zemplén
ZIP/Postal Code
3530
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Trial Pharma Kft.
City
Békéscsaba
State/Province
Békés
ZIP/Postal Code
5600
Country
Hungary
Individual Site Status
Suspended
Facility Name
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
City
Szeged
State/Province
Csongrád
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Suspended
Facility Name
Sonocor Egészségügyi Szolgáltató Kft.
City
Szeged
State/Province
Csongrád
ZIP/Postal Code
6725
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
TaNa Med Kft
City
Mosonmagyaróvár
State/Province
Gyor-Moson-Sopron
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Markhot Ferenc Oktatókórház és Rendelőintézet
City
Eger
State/Province
Heves
ZIP/Postal Code
3300
Country
Hungary
Individual Site Status
Suspended
Facility Name
BKS Research
City
Hatvan
State/Province
Heves
ZIP/Postal Code
H-3000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Kistarcsai Flor Ferenc Korhaz
City
Kistarcsa Hungary
State/Province
Pest
ZIP/Postal Code
2143
Country
Hungary
Individual Site Status
Recruiting
Facility Name
DRC Gyógyszervizsgáló Központ Kft.
City
Balatonfüred
State/Province
Veszprém City
ZIP/Postal Code
8230
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
ZIP/Postal Code
H-7400
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Rabin Medical Center
City
Petah Tikwa
State/Province
HaMerkaz
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Western Galilee Hospital
City
Nahariya
State/Province
HaZafon
ZIP/Postal Code
22100
Country
Israel
Individual Site Status
Suspended
Facility Name
Nazareth Hospital EMMS
City
Nazareth
State/Province
HaZafon
ZIP/Postal Code
16100
Country
Israel
Individual Site Status
Suspended
Facility Name
The Barzilai Medical Center - Nephrology and Hypertension
City
Ashkelon
State/Province
Tel-Aviv
ZIP/Postal Code
522621
Country
Israel
Individual Site Status
Suspended
Facility Name
Shaare Zedek Medical Center - Internal Medicine
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Individual Site Status
Suspended
Facility Name
Chungnam National University Hospital - Nephrology
City
Daejeon
State/Province
Daejeon Gwang'yeogsi [Taejon-Kwangyokshi]
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
National Health Insurance Service Ilsan Hospital - Nephrology
City
Goyang-si
State/Province
Gyeonggido [Kyonggi-do]
ZIP/Postal Code
10444
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital - Nephrology
City
Jongno-gu
State/Province
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Gangnam Severance Hospital, Yonsei University Health System - Internal Medicine
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
ZIP/Postal Code
6273
Country
Korea, Republic of
Individual Site Status
Suspended
Facility Name
Samsung Medical Center - Nephrology
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
ZIP/Postal Code
6351
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
ZIP/Postal Code
6591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Saules seimos medicinos centras
City
Kaunas
State/Province
Kauno Apskritis
ZIP/Postal Code
LT-49449
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Hospital Raja Perempuan Zainab II
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
15586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30450
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Seri Manjung
City
Seri Manjung
State/Province
Perak
ZIP/Postal Code
32400
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
State/Province
Wilayah Persekutuan Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
State/Province
Wilayah Persekutuan Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Amsterdam UMC location Vumc
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Suspended
Facility Name
VU Medisch Centrum
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Suspended
Facility Name
Meander Medisch Centrum
City
Amersfoort
State/Province
Utrecht
ZIP/Postal Code
3813 TZ
Country
Netherlands
Individual Site Status
Suspended
Facility Name
Albert Schweitzer Ziekenhuis - Dordwijk
City
Dordrecht
State/Province
Zuid-Holland
ZIP/Postal Code
3300 AK
Country
Netherlands
Individual Site Status
Suspended
Facility Name
Amphia Ziekenhuis (Ignatius Hospital) - Locatie Molengracht
City
Breda
ZIP/Postal Code
4818 RK
Country
Netherlands
Individual Site Status
Suspended
Facility Name
NZOZ Euromedica Sp. z o.o.
City
Grudziądz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
86-300
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer
City
Lodz
State/Province
Lódzkie
ZIP/Postal Code
94-074
Country
Poland
Individual Site Status
Recruiting
Facility Name
Synexus Polska Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Synexus Polska Sp. z. o.o.
City
Lodz
ZIP/Postal Code
90127
Country
Poland
Individual Site Status
Recruiting
Facility Name
SP ZOZ Centralny Szpital Kliniczny UM w Lodzi
City
Lodz
ZIP/Postal Code
92-213
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
City
Lublin
ZIP/Postal Code
20954
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Synexus Polska Sp. z o.o.
City
Mazowieckie
ZIP/Postal Code
02-672
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Synexus Polska Sp. z o.o.
City
Poznan
ZIP/Postal Code
60-702
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
WroMedica I. Bielicka, A. Strzalkowska s.c.
City
Wrocław
ZIP/Postal Code
51-685
Country
Poland
Individual Site Status
Suspended
Facility Name
Clinical Hospital Centre Zemun
City
Zemun
State/Province
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinical Centre Nis
City
Niš
State/Province
Nišavski Okrug
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Clinical Center Vojvodina
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Zvezdara University Medical Center
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
MSB General hospital - Clinical Research Center
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
33126-3422
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Iatros International
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Charlotte Maxeke Johannesburg Hospital
City
Soweto
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Office of Gulam Hoosain Vally
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4001
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Tiervlei Trial Centre
City
Bellville, Cape Town
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Dr J.M. Engelbrecht Trial Site
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hospital público da Mariña
City
Burela
State/Province
Lugo
ZIP/Postal Code
27880
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Ribera Polusa
City
Burela
State/Province
Lugo
ZIP/Postal Code
27880
Country
Spain
Individual Site Status
Recruiting
Facility Name
Consorcio Hospital General Universitario de Valencia
City
Valencia
State/Province
Valenciana, Comunidad
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Name
FUNDACION PUIGVERT - Nephrology Department
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Quironsalud Barcelona
City
Barcelona
ZIP/Postal Code
8023
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Y Politécnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Taichung Veterans General Hospital - Nephrology
City
Taichung
State/Province
Taichung Municipality
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
National Taiwan University Hospital - Nephrology
City
Taipei
State/Province
Taipei Special Muncipality
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
China Medical University Hospital - Nephrology - Taichung
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Medical University - Shuang Ho Hospital - Nephrology
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Nephrology
City
Taoyuan County
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Hacettepe Universitesi Hastaneleri (Hacettepe University Hos)
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Akdeniz University Medical Faculty
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Trakya University Medical Faculty
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Bati Anadolu Universitesi (University of Western Anatolia) (UNWA) - BatiAnadolu Hastanesi Central Hospital - Izmir
City
İzmir
ZIP/Postal Code
35010
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Erciyes Universitesi Tip Fakultesi
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Kocaeli University Research and Application Hospital
City
Kocaeli
ZIP/Postal Code
41001
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Mersin University Medical Faculty
City
Mersin
ZIP/Postal Code
33110
Country
Turkey
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe CKD

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