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A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease

Primary Purpose

Kidney Disease, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 690517
Placebo to BI 690517
Empagliflozin
Placebo to empagliflozin
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Disease, Chronic

Eligibility Criteria

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

Inclusion criteria

  • Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
  • Male or female patients of legal adult age (according to local legislation) and aged ≥ 18 years at time of consent.
  • estimated Glomerular Filtration Rate (eGFR, Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥ 30 and < 90 mL/min/1.73 m2 at Visit 1 by central laboratory analysis.
  • Urine Albumin Creatinine Ratio (UACR) ≥ 200 and < 5,000 mg/g in spot urine (midstream urine sample) by central laboratory analysis at Visit 1.1
  • If the patient is taking any of the following medications they should be on a stable dose for at least 4 weeks prior to visit 1 and until first randomisation prior to run-in with no planned change of the therapy during the trial: anti-hypertensives, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), endothelin receptor antagonists, low dose systemic steroids (e.g. prednisolone ≤10 mg or equivalent).
  • Treatment with a clinically appropriate, stable dose of either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) (but not both together), for ≥ 4 weeks prior to visit 1 and until first randomisation with no planned change of the therapy during the trial.
  • In the Investigator's opinion, any kind of diagnosed chronic kidney disease (Diagnosis can be reached by standard clinical method, no biopsy required). Patients with diabetic kidney disease must have type 2 diabetes mellitus and their treatment (including GLP1 receptor agonist) should be unchanged or changes deemed minor (according to investigator's judgement) within 4 weeks prior to Visit 1 and until first randomisation.
  • Glycated Haemoglobin (HbA1c) < 10.0% at Visit 1 measured by the central laboratory.
  • Serum potassium ≤ 4.8 mmol/L at Visit 1 measured by the central laboratory.
  • Seated Systolic Blood Pressure (SBP) ≥ 110 and ≤ 160 mmHg and Diastolic Blood Pressure (DBP) ≥ 65 and ≤ 110 mmHg at Visit 1 (mean values from three Blood Pressure (BP) measurements) and optimised anti-hypertensive treatment according to local standard of care and investigator's judgement.
  • Body Mass Index (BMI) ≥ 18.5 and < 50 kg/m2 at Visit 1.
  • Women of child-bearing potential2 (WOCBP) must be ready and able to use highly effective methods of birth control. Such methods should be used throughout the trial. Men must be vasectomised or willing and able to use a condom if their partner is a WOCBP.

Additional inclusion criteria to be assessed before second randomisation (start of Treatment Period):

  • Serum potassium ≤ 4.8 mmol/L measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.
  • eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥ 20 mL/min/1.73 m2 measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.

Exclusion criteria

  • Treatment with inhibitors of aldosterone mediated effects (e.g., mineralocorticoid receptor antagonists such as spironolactone), or intake of other potassium sparing diuretics (e.g., amiloride) within 7 days prior to first randomisation or planned during trial treatment phase.
  • Treatment with other Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)) within 4 weeks prior to Visit 1 and throughout screening or planned during the trial. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial are also excluded.
  • Type 1 diabetes mellitus, or history of other autoimmune causes of diabetes mellitus (e.g. Latent Autoimmune Diabetes (LADA))
  • Patients at increased risk of ketoacidosis in the opinion of the investigator.
  • Currently receiving Sodium-glucose cotransporter (SGLT)-2 or SGLT-1/2 inhibitor or planned initiation during the trial.

Further criteria apply.

Sites / Locations

  • Aventiv Research Inc.
  • AKDHC Medical Research Services, LLC
  • Clearview Medical Research, LLC
  • Pacific Renal Associates
  • Amicis Research Center
  • Valley Clinical Trials, Inc.
  • California Kidney Specialists
  • Colorado Kidney Care
  • Clinical Research of Brandon LLC
  • Horizon Research Group
  • Elixia Fort Lauderdale, LLC
  • South Florida Research Institute
  • San Marcus Research Clinic, Inc.
  • Total Research Group, LLC
  • Horizon Research Group, LLC
  • West Orange Endocrinology
  • Pines Care Research Center
  • Elixia Tampa, LLC
  • Boise Kidney and Hypertension PLLC
  • Cedar Crosse Research Center
  • Kansas Nephrology Research Institute, LLC
  • Aa Mrc Llc
  • Elite Research Center, LLC
  • Clinical Research Consultants, LLC
  • Forte Family Practice
  • New Mexico Clinical Research and Osteoporosis Center, Inc.
  • Triad Internal Medicine
  • Lucas Research, Inc.
  • Diabetes & Endocrinology Associates of Stark County
  • Cleveland Clinic
  • Heritage Valley Medical Group
  • Elixia Upland, LLC
  • Monument Health
  • Knoxville Kidney Center PLLC
  • Research Institute of Dallas
  • Academy Of Diabetes, Thyroid And Endocrine, PA
  • PrimeCare Medical Group
  • P&I Clinical Research, LLC
  • Simcare Medical Research, LLC
  • Providence Medical Research Center
  • Universal Research Group, LLC
  • CIMEL centro de Investigaciones Médicas Lanús
  • CEDIC - Centro de Investigacion Clinica
  • Glenny Corp. S.A. Bioclinica Argentina
  • Instituto Privado de Investigaciones Clínica Córdoba S.A.
  • Centro de Salud Renal Junín
  • Centro de Investigaciones Médicas Mar del Plata
  • Instituto Médico Catamarca - IMEC
  • CEMEDIC - Centro de Especialidades Medicas
  • John Hunter Hospital
  • Monash University
  • St Vincent's Hospital Melbourne
  • Brussels - UNIV UZ Brussel
  • Brussels - UNIV Saint-Luc
  • La Louvière - UNIV CHU Tivoli
  • UZ Leuven
  • Charleroi - UNIV CHU de Charleroi
  • Hospital Universitário João de Barros Barreto
  • Faculdade de Medicina de Botucatu - UNESP
  • Fundação Pró Renal Brasil
  • Universidade Federal do Rio Grande do Sul
  • Ruschel Medicina e Pesquisa Clínica
  • Centro de Pesquisa Clinica - CPCLIN
  • BR Trials
  • CEMEC - Centro Multidisciplinar de Estudos Clínicos
  • Hospital do RIM - UNIFESP
  • Medical Center Rusemed
  • Robert Koch Clinic Sofia
  • Medical Center Synexus Sofia EOOD
  • MHAT Prof Stoyan Kirkovich AD
  • The Bailey Clinic
  • LMC Clinical Research Inc. (Brampton)
  • Toronto General Hospital
  • Sameh Fikry Medicine Professional Corporation
  • Shivinder Jolly, Nephrologist
  • Recherche GCP Research
  • Guangdong Provincial People's Hospital
  • The First Afiliated Hospital, Sun Yet-sen University
  • Zhejiang Province People's Hospital
  • The First People's Hospital of Nanning
  • Huashan Hospital, Fudan University
  • Shanghai Fifth People's Hospital affiliated to Fudan University
  • DIKa centrum s.r.o.
  • Synexus Czech s.r.o.
  • MILAN KVAPIL s.r.o.
  • Hospital Slany, Internal Department
  • Satucon Oy
  • Tampere University Hospital
  • Turku University Hospital / TYKS
  • Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
  • Institut für klinische Forschung und Entwicklung (IKFE) Berlin GmbH
  • Cardiologicum Dresden und Pirna
  • Universitätsklinikum Carl Gustav Carus Dresden
  • DaVita Clinical Research Germany GmbH
  • Synexus Clinical Research GmbH
  • Medizinische Hochschule Hannover
  • Synexus Clinical Research GmbH
  • Universitätsklinikum Würzburg AÖR
  • General Hospital of Athens "Laiko"
  • "Attiko" Hospital of Athens
  • Univ. Gen. Hosp. of Ioannina
  • Iatriko of Athens Group/ Iatriko of P. Faliro
  • Prince of Wales Hospital
  • Queen Mary Hospital
  • Lausmed Kft. Outpatient Unit of Internal Medicine
  • DRC Drug Research Ltd
  • Synexus Hungary Healthcare Service Ltd.
  • Semmelweis University
  • University Debrecen Hospital
  • Markhot Ferenc Hospital, Eger
  • BKS Research Ltd
  • Government Medical College & Hospital
  • SMS Medical College and HospitaL
  • Jaipur National University Institute for Medical Science & Research Centre
  • Ganesh Shankar Vidyarthi Memorial Medical College
  • K R Hospital Mysore Medical College and Research Centre
  • Kingsway Hospitals
  • All India Institute of Medical Sciences
  • Shree Giriraj Multispeciality Hospital
  • Galaxy Lifecare Services Pvt. Ltd.
  • Christian Medical College
  • A.O. Policlinico Giovanni XXIII di Bari
  • ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII
  • Daiyukai Clinic
  • Meitetsu Hospital
  • Nagoya Kyoritsu Hospital
  • TOSAKI Clinic for Diabetes and Endocrinology
  • National Hospital Organization Takasaki General Medical Center
  • Kyoto Okamoto Memorial Hospital
  • Ina Central Hospital
  • Suwa Red Cross Hospital
  • Asano Clinic
  • Omihachiman Community Medical Center
  • The University of Tokyo Hospital
  • Tokyo Medical University Hachioji Medical Center
  • Miho Clinic
  • Yamaura Medical Clinic
  • Korea University Ansan Hospital
  • Chungbuk National University Hospital
  • Inje University Ilsan Paik Hospital
  • Seoul National University Hospital
  • Severance Hospital
  • SMG-SNU Boramae Medical Center
  • Hospital Selayang
  • University Kebangsaan Malaysia
  • Klinik Kesihatan Mahmoodiah
  • Tuanku Fauziah Hospital
  • Hospital Raja Perempuan Zainab II, Kota Bharu
  • Hospital Seri Manjung
  • Centro de Investigacion Cardiometabolica de Aguascalientes
  • Unidad de Investigación Clinica y Atencion Medica HEPA SC
  • Centro Mexicano de Desarrollo de Estudios Clínicos SA -CEMDEC
  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
  • Clinstile S.A. de C.V.
  • CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc
  • Hospital Universitario Dr Jose Eleuterio Gonzalez
  • Akershus Universitetssykehus HF
  • Helse Stavanger, Stavanger Universitetssykehus
  • Norzel Medical and Diagnostic Clinic
  • Davao Doctors Hospital
  • West Visayas State University Medical Center
  • Institute for Studies on Diabetes Foundation Inc.
  • The Medical City
  • Philippine Heart Center
  • Senor Santo Nino Hospital
  • INTERCORE Medical Center
  • Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk
  • Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice
  • Pro Familia Altera
  • Synexus Lodz Medical Center
  • Clinical Best Solutions
  • NZOZ Specialized Ambulance "MEDICA"
  • Hospitals of Tczew S.A.
  • Omedica Medical Centre, Poznan
  • Synexus Poland, Branch in Poznan
  • Independent Health Care Center HCP Medical Center
  • Centrum Medyczne Synexus
  • Barwijuk Clinics
  • Synexus Poland, Branch in Wroclaw
  • Hospital Garcia de Orta, EPE
  • Centro Hospitalar do Baixo Vouga - Hospital Infante Dom Pedro
  • CHLO, EPE - Hospital de Santa Cruz
  • Centro Hosp. de Leiria-Pombal
  • APDP - Associação Protectora dos Diabéticos de Portugal
  • Centro Hospitalar de Vila Nova de Gaia
  • Iatros International
  • Synexus Helderberg Clinical Research Centre
  • TREAD Research
  • Langeberg Clinical Trials
  • Paarl Research Centre
  • Latiff, GHVM
  • DJW Navorsing
  • Synexus Watermeyer Clinical Research Centre
  • Hospital Vall d'Hebron
  • Hospital Público Da Mariña
  • Hospital Universitario Reina Sofía
  • Fundación Jiménez Díaz
  • Hospital Puerta de Hierro
  • Centralsjukhuset, Kristianstad
  • Universitetssjukhuset, Linköping
  • Citydiabetes, Stockholm
  • University Hospital of Lausanne
  • Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Treatment period: Empagliflozin + BI 690517

Treatment period: Empagliflozin + Placebo to BI 690517

Treatment period: Placebo to Empagliflozin + BI 690517

Treatment period: Placebo to Empagliflozin + Placebo to BI 690517

Arm Description

Outcomes

Primary Outcome Measures

Change from treatment period baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in First Morning Void urine

Secondary Outcome Measures

UACR response I, defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline
UACR response II, defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline

Full Information

First Posted
January 5, 2022
Last Updated
September 29, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05182840
Brief Title
A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease
Official Title
Randomised, Double-blind, Placebo-controlled and Parallel Dose Group Trial to Investigate Efficacy and Safety of Multiple Doses of Oral BI 690517 Over 14 Weeks, Alone and in Combination With Empagliflozin, in Patients With Diabetic and Non-diabetic Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
June 19, 2023 (Actual)
Study Completion Date
July 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

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 study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study. The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function in people with chronic kidney disease when taken alone or in combination with a medicine called empagliflozin. In the first part of the study, participants take empagliflozin or placebo as tablets every day for 2 months. Placebo tablets look like empagliflozin tablets but do not contain any medicine. In the second part, participants are divided into several groups. Depending on the group, the participants then additionally take different doses of BI 690517 or placebo as tablets for 3.5 months. In this case, placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants are in the study for about 6 months. During this time, they visit the study site about 12 times. Where possible, about 4 of the 12 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Participants collect urine samples at home. These samples are then analysed to assess kidney function. At the end of the trial the results are compared between the different groups. The doctors also regularly check participants' health and take note of any unwanted effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
714 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment period: Empagliflozin + BI 690517
Arm Type
Experimental
Arm Title
Treatment period: Empagliflozin + Placebo to BI 690517
Arm Type
Experimental
Arm Title
Treatment period: Placebo to Empagliflozin + BI 690517
Arm Type
Experimental
Arm Title
Treatment period: Placebo to Empagliflozin + Placebo to BI 690517
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BI 690517
Intervention Description
BI 690517
Intervention Type
Drug
Intervention Name(s)
Placebo to BI 690517
Intervention Description
Placebo to BI 690517
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Intervention Description
Empagliflozin
Intervention Type
Drug
Intervention Name(s)
Placebo to empagliflozin
Intervention Description
Placebo to empagliflozin
Primary Outcome Measure Information:
Title
Change from treatment period baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in First Morning Void urine
Time Frame
up to 14 weeks
Secondary Outcome Measure Information:
Title
UACR response I, defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline
Time Frame
up to 14 weeks
Title
UACR response II, defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline
Time Frame
up to 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. Male or female patients of legal adult age (according to local legislation) and aged ≥ 18 years at time of consent. estimated Glomerular Filtration Rate (eGFR, Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥ 30 and < 90 mL/min/1.73 m2 at Visit 1 by central laboratory analysis. Urine Albumin Creatinine Ratio (UACR) ≥ 200 and < 5,000 mg/g in spot urine (midstream urine sample) by central laboratory analysis at Visit 1.1 If the patient is taking any of the following medications they should be on a stable dose for at least 4 weeks prior to visit 1 and until first randomisation prior to run-in with no planned change of the therapy during the trial: anti-hypertensives, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), endothelin receptor antagonists, low dose systemic steroids (e.g. prednisolone ≤10 mg or equivalent). Treatment with a clinically appropriate, stable dose of either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) (but not both together), for ≥ 4 weeks prior to visit 1 and until first randomisation with no planned change of the therapy during the trial. In the Investigator's opinion, any kind of diagnosed chronic kidney disease (Diagnosis can be reached by standard clinical method, no biopsy required). Patients with diabetic kidney disease must have type 2 diabetes mellitus and their treatment (including GLP1 receptor agonist) should be unchanged or changes deemed minor (according to investigator's judgement) within 4 weeks prior to Visit 1 and until first randomisation. Glycated Haemoglobin (HbA1c) < 10.0% at Visit 1 measured by the central laboratory. Serum potassium ≤ 4.8 mmol/L at Visit 1 measured by the central laboratory. Seated Systolic Blood Pressure (SBP) ≥ 110 and ≤ 160 mmHg and Diastolic Blood Pressure (DBP) ≥ 65 and ≤ 110 mmHg at Visit 1 (mean values from three Blood Pressure (BP) measurements) and optimised anti-hypertensive treatment according to local standard of care and investigator's judgement. Body Mass Index (BMI) ≥ 18.5 and < 50 kg/m2 at Visit 1. Women of child-bearing potential2 (WOCBP) must be ready and able to use highly effective methods of birth control. Such methods should be used throughout the trial. Men must be vasectomised or willing and able to use a condom if their partner is a WOCBP. Additional inclusion criteria to be assessed before second randomisation (start of Treatment Period): Serum potassium ≤ 4.8 mmol/L measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period. eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥ 20 mL/min/1.73 m2 measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period. Exclusion criteria Treatment with inhibitors of aldosterone mediated effects (e.g., mineralocorticoid receptor antagonists such as spironolactone), or intake of other potassium sparing diuretics (e.g., amiloride) within 7 days prior to first randomisation or planned during trial treatment phase. Treatment with other Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)) within 4 weeks prior to Visit 1 and throughout screening or planned during the trial. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial are also excluded. Type 1 diabetes mellitus, or history of other autoimmune causes of diabetes mellitus (e.g. Latent Autoimmune Diabetes (LADA)) Patients at increased risk of ketoacidosis in the opinion of the investigator. Currently receiving Sodium-glucose cotransporter (SGLT)-2 or SGLT-1/2 inhibitor or planned initiation during the trial. Further criteria apply.
Facility Information:
Facility Name
Aventiv Research Inc.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
AKDHC Medical Research Services, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Clearview Medical Research, LLC
City
Canyon Country
State/Province
California
ZIP/Postal Code
91351
Country
United States
Facility Name
Pacific Renal Associates
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Amicis Research Center
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Valley Clinical Trials, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
California Kidney Specialists
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
Colorado Kidney Care
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Clinical Research of Brandon LLC
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Horizon Research Group
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Elixia Fort Lauderdale, LLC
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
South Florida Research Institute
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Facility Name
San Marcus Research Clinic, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Total Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Horizon Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33150
Country
United States
Facility Name
West Orange Endocrinology
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Pines Care Research Center
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Elixia Tampa, LLC
City
Temple Terrace
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
Facility Name
Boise Kidney and Hypertension PLLC
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
Cedar Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Kansas Nephrology Research Institute, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Aa Mrc Llc
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Elite Research Center, LLC
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Clinical Research Consultants, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Forte Family Practice
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89103
Country
United States
Facility Name
New Mexico Clinical Research and Osteoporosis Center, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Triad Internal Medicine
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
Lucas Research, Inc.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Diabetes & Endocrinology Associates of Stark County
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Heritage Valley Medical Group
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Elixia Upland, LLC
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Monument Health
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Knoxville Kidney Center PLLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Academy Of Diabetes, Thyroid And Endocrine, PA
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Facility Name
PrimeCare Medical Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
P&I Clinical Research, LLC
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
Simcare Medical Research, LLC
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Providence Medical Research Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Universal Research Group, LLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
CIMEL centro de Investigaciones Médicas Lanús
City
Buenos Aires
ZIP/Postal Code
B1824KAJ
Country
Argentina
Facility Name
CEDIC - Centro de Investigacion Clinica
City
Caba
ZIP/Postal Code
C1060ABN
Country
Argentina
Facility Name
Glenny Corp. S.A. Bioclinica Argentina
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1430CKE
Country
Argentina
Facility Name
Instituto Privado de Investigaciones Clínica Córdoba S.A.
City
Cordoba
ZIP/Postal Code
X5000AAW
Country
Argentina
Facility Name
Centro de Salud Renal Junín
City
Junín
ZIP/Postal Code
B6000GMA
Country
Argentina
Facility Name
Centro de Investigaciones Médicas Mar del Plata
City
Mar del Plata
ZIP/Postal Code
B7600FYK
Country
Argentina
Facility Name
Instituto Médico Catamarca - IMEC
City
Rosario
ZIP/Postal Code
S2000AJU
Country
Argentina
Facility Name
CEMEDIC - Centro de Especialidades Medicas
City
Villa Luro
ZIP/Postal Code
C1440CFD
Country
Argentina
Facility Name
John Hunter Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Monash University
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Brussels - UNIV UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Brussels - UNIV Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
La Louvière - UNIV CHU Tivoli
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Charleroi - UNIV CHU de Charleroi
City
Lodelinsart
ZIP/Postal Code
6042
Country
Belgium
Facility Name
Hospital Universitário João de Barros Barreto
City
Belém
ZIP/Postal Code
CEP 66073-
Country
Brazil
Facility Name
Faculdade de Medicina de Botucatu - UNESP
City
Botucatu
ZIP/Postal Code
18618-687
Country
Brazil
Facility Name
Fundação Pró Renal Brasil
City
Curitiba
ZIP/Postal Code
80440-020
Country
Brazil
Facility Name
Universidade Federal do Rio Grande do Sul
City
Porto Alegre
ZIP/Postal Code
90430-001
Country
Brazil
Facility Name
Ruschel Medicina e Pesquisa Clínica
City
Rio de Janeiro
ZIP/Postal Code
22270-060
Country
Brazil
Facility Name
Centro de Pesquisa Clinica - CPCLIN
City
Sao Paulo
ZIP/Postal Code
01244-030
Country
Brazil
Facility Name
BR Trials
City
Sao Paulo
ZIP/Postal Code
05003090
Country
Brazil
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clínicos
City
São Bernardo do Campo
ZIP/Postal Code
09780-000
Country
Brazil
Facility Name
Hospital do RIM - UNIFESP
City
São Paulo
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
Medical Center Rusemed
City
Ruse
ZIP/Postal Code
7013
Country
Bulgaria
Facility Name
Robert Koch Clinic Sofia
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Medical Center Synexus Sofia EOOD
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
MHAT Prof Stoyan Kirkovich AD
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
The Bailey Clinic
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
LMC Clinical Research Inc. (Brampton)
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6S 0C6
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Sameh Fikry Medicine Professional Corporation
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Shivinder Jolly, Nephrologist
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2T 0C1
Country
Canada
Facility Name
Recherche GCP Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
The First Afiliated Hospital, Sun Yet-sen University
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Zhejiang Province People's Hospital
City
Hangzhou
ZIP/Postal Code
310014
Country
China
Facility Name
The First People's Hospital of Nanning
City
Nanning
ZIP/Postal Code
530000
Country
China
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Fifth People's Hospital affiliated to Fudan University
City
Shanghai
ZIP/Postal Code
200240
Country
China
Facility Name
DIKa centrum s.r.o.
City
Havirov
ZIP/Postal Code
73601
Country
Czechia
Facility Name
Synexus Czech s.r.o.
City
Prague
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
MILAN KVAPIL s.r.o.
City
Pribram
ZIP/Postal Code
26101
Country
Czechia
Facility Name
Hospital Slany, Internal Department
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
Satucon Oy
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Turku University Hospital / TYKS
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Institut für klinische Forschung und Entwicklung (IKFE) Berlin GmbH
City
Berlin
ZIP/Postal Code
10437
Country
Germany
Facility Name
Cardiologicum Dresden und Pirna
City
Dresden
ZIP/Postal Code
01277
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
DaVita Clinical Research Germany GmbH
City
Düsseldorf
ZIP/Postal Code
40210
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Frankfurt
ZIP/Postal Code
60313
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinikum Würzburg AÖR
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
General Hospital of Athens "Laiko"
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
"Attiko" Hospital of Athens
City
Athens
ZIP/Postal Code
124 62
Country
Greece
Facility Name
Univ. Gen. Hosp. of Ioannina
City
Ioannina
ZIP/Postal Code
455 00
Country
Greece
Facility Name
Iatriko of Athens Group/ Iatriko of P. Faliro
City
P. Faliro
ZIP/Postal Code
17562
Country
Greece
Facility Name
Prince of Wales Hospital
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Lausmed Kft. Outpatient Unit of Internal Medicine
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
DRC Drug Research Ltd
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Synexus Hungary Healthcare Service Ltd.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
University Debrecen Hospital
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Markhot Ferenc Hospital, Eger
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
BKS Research Ltd
City
Hatvan
ZIP/Postal Code
3000
Country
Hungary
Facility Name
Government Medical College & Hospital
City
Aurangabad
ZIP/Postal Code
431001
Country
India
Facility Name
SMS Medical College and HospitaL
City
Jaipur
ZIP/Postal Code
302001
Country
India
Facility Name
Jaipur National University Institute for Medical Science & Research Centre
City
Jaipur
ZIP/Postal Code
302017
Country
India
Facility Name
Ganesh Shankar Vidyarthi Memorial Medical College
City
Kanpur
ZIP/Postal Code
208002
Country
India
Facility Name
K R Hospital Mysore Medical College and Research Centre
City
Mysore
ZIP/Postal Code
570001
Country
India
Facility Name
Kingsway Hospitals
City
Nagpur
ZIP/Postal Code
440001
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Shree Giriraj Multispeciality Hospital
City
Rajkot
ZIP/Postal Code
360005
Country
India
Facility Name
Galaxy Lifecare Services Pvt. Ltd.
City
Varanasi
ZIP/Postal Code
221010
Country
India
Facility Name
Christian Medical College
City
Vellore
ZIP/Postal Code
632004
Country
India
Facility Name
A.O. Policlinico Giovanni XXIII di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Daiyukai Clinic
City
Aichi, Ichinomiya
ZIP/Postal Code
491-8551
Country
Japan
Facility Name
Meitetsu Hospital
City
Aichi, Nagoya
ZIP/Postal Code
451-8511
Country
Japan
Facility Name
Nagoya Kyoritsu Hospital
City
Aichi, Nagoya
ZIP/Postal Code
454-0933
Country
Japan
Facility Name
TOSAKI Clinic for Diabetes and Endocrinology
City
Aichi, Nagoya
ZIP/Postal Code
468-0009
Country
Japan
Facility Name
National Hospital Organization Takasaki General Medical Center
City
Gumma, Takasaki
ZIP/Postal Code
370-0829
Country
Japan
Facility Name
Kyoto Okamoto Memorial Hospital
City
Kyoto, Kuse-gun
ZIP/Postal Code
613-0034
Country
Japan
Facility Name
Ina Central Hospital
City
Nagano, Ina
ZIP/Postal Code
396-8555
Country
Japan
Facility Name
Suwa Red Cross Hospital
City
Nagano, Suwa
ZIP/Postal Code
392-8510
Country
Japan
Facility Name
Asano Clinic
City
Saitama, Kawagoe
ZIP/Postal Code
350-0851
Country
Japan
Facility Name
Omihachiman Community Medical Center
City
Shiga, Omihachiman
ZIP/Postal Code
523-0082
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Tokyo, Bunkyo-ku
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Tokyo Medical University Hachioji Medical Center
City
Tokyo, Hachioji
ZIP/Postal Code
193-0998
Country
Japan
Facility Name
Miho Clinic
City
Tokyo, Shinagawa-ku
ZIP/Postal Code
141-0032
Country
Japan
Facility Name
Yamaura Medical Clinic
City
Ueda, Nagano
ZIP/Postal Code
386-0407
Country
Japan
Facility Name
Korea University Ansan Hospital
City
Ansan
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Cheongiu
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Goyang
ZIP/Postal Code
10380
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
Hospital Selayang
City
Batu Caves
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
University Kebangsaan Malaysia
City
Cheras, Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Klinik Kesihatan Mahmoodiah
City
Johor Bahru
ZIP/Postal Code
80100
Country
Malaysia
Facility Name
Tuanku Fauziah Hospital
City
Kangar
ZIP/Postal Code
01000
Country
Malaysia
Facility Name
Hospital Raja Perempuan Zainab II, Kota Bharu
City
Kota Bharu
ZIP/Postal Code
15200
Country
Malaysia
Facility Name
Hospital Seri Manjung
City
Seri Manjung
ZIP/Postal Code
32040
Country
Malaysia
Facility Name
Centro de Investigacion Cardiometabolica de Aguascalientes
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Unidad de Investigación Clinica y Atencion Medica HEPA SC
City
Guadalajara
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Centro Mexicano de Desarrollo de Estudios Clínicos SA -CEMDEC
City
Mexico
ZIP/Postal Code
06100
Country
Mexico
Facility Name
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
City
Mexico
ZIP/Postal Code
20010
Country
Mexico
Facility Name
Clinstile S.A. de C.V.
City
México
ZIP/Postal Code
06700
Country
Mexico
Facility Name
CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc
City
México
ZIP/Postal Code
11650
Country
Mexico
Facility Name
Hospital Universitario Dr Jose Eleuterio Gonzalez
City
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Akershus Universitetssykehus HF
City
Nordbyhagen
ZIP/Postal Code
1478
Country
Norway
Facility Name
Helse Stavanger, Stavanger Universitetssykehus
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Norzel Medical and Diagnostic Clinic
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Davao Doctors Hospital
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
West Visayas State University Medical Center
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Institute for Studies on Diabetes Foundation Inc.
City
Marikina city
ZIP/Postal Code
1810
Country
Philippines
Facility Name
The Medical City
City
Pasig City
ZIP/Postal Code
1605
Country
Philippines
Facility Name
Philippine Heart Center
City
Quezon City
ZIP/Postal Code
850
Country
Philippines
Facility Name
Senor Santo Nino Hospital
City
Tarlac
ZIP/Postal Code
2306
Country
Philippines
Facility Name
INTERCORE Medical Center
City
Bydgoszcz
ZIP/Postal Code
85-605
Country
Poland
Facility Name
Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk
City
Gdansk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Pro Familia Altera
City
Katowice
ZIP/Postal Code
40-648
Country
Poland
Facility Name
Synexus Lodz Medical Center
City
Lodz
ZIP/Postal Code
90127
Country
Poland
Facility Name
Clinical Best Solutions
City
Lublin
ZIP/Postal Code
20-078
Country
Poland
Facility Name
NZOZ Specialized Ambulance "MEDICA"
City
Lublin
ZIP/Postal Code
20-538
Country
Poland
Facility Name
Hospitals of Tczew S.A.
City
Pomorskie
ZIP/Postal Code
83-110
Country
Poland
Facility Name
Omedica Medical Centre, Poznan
City
Poznan
ZIP/Postal Code
60-111
Country
Poland
Facility Name
Synexus Poland, Branch in Poznan
City
Poznan
ZIP/Postal Code
60-702
Country
Poland
Facility Name
Independent Health Care Center HCP Medical Center
City
Poznan
ZIP/Postal Code
61-485
Country
Poland
Facility Name
Centrum Medyczne Synexus
City
Warszawa
ZIP/Postal Code
02-672
Country
Poland
Facility Name
Barwijuk Clinics
City
Warszawa
ZIP/Postal Code
02-884
Country
Poland
Facility Name
Synexus Poland, Branch in Wroclaw
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
Hospital Garcia de Orta, EPE
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
Centro Hospitalar do Baixo Vouga - Hospital Infante Dom Pedro
City
Aveiro
ZIP/Postal Code
3810-164
Country
Portugal
Facility Name
CHLO, EPE - Hospital de Santa Cruz
City
Carnaxide
ZIP/Postal Code
2790-134
Country
Portugal
Facility Name
Centro Hosp. de Leiria-Pombal
City
Leiria
ZIP/Postal Code
2410-197
Country
Portugal
Facility Name
APDP - Associação Protectora dos Diabéticos de Portugal
City
Lisboa
ZIP/Postal Code
1250-189
Country
Portugal
Facility Name
Centro Hospitalar de Vila Nova de Gaia
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Iatros International
City
Bloemfontein
ZIP/Postal Code
9324
Country
South Africa
Facility Name
Synexus Helderberg Clinical Research Centre
City
Cape Town
ZIP/Postal Code
7130
Country
South Africa
Facility Name
TREAD Research
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Langeberg Clinical Trials
City
Cape Town
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Paarl Research Centre
City
Cape Town
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Latiff, GHVM
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
DJW Navorsing
City
Krugersdorp
ZIP/Postal Code
1739
Country
South Africa
Facility Name
Synexus Watermeyer Clinical Research Centre
City
Pretoria
ZIP/Postal Code
0184
Country
South Africa
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Público Da Mariña
City
Burela
ZIP/Postal Code
27880
Country
Spain
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Centralsjukhuset, Kristianstad
City
Kristianstad
ZIP/Postal Code
291 33
Country
Sweden
Facility Name
Universitetssjukhuset, Linköping
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Citydiabetes, Stockholm
City
Stockholm
ZIP/Postal Code
112 21
Country
Sweden
Facility Name
University Hospital of Lausanne
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Istanbul University
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Once the time frame criteria given under number 4 are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
IPD Sharing Time Frame
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
http://www.mystudywindow.com/
Description
Related Info

Learn more about this trial

A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease

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