Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe CKD (Clarion-CKD)
Chronic Kidney Diseases
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
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
Placebo Comparator
Experimental
Placebo
KBP-5074
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.