MedPath

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

Phase 2
Completed
Conditions
Kidney Disease, Chronic
Interventions
Registration Number
NCT05182840
Lead Sponsor
Boehringer Ingelheim
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
714
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517BI 690517-
Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517BI 690517-
Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517BI 690517-
Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517Placebo to BI 690517-
Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517Placebo to empagliflozin-
Run-in period: 10 mg empagliflozinEmpagliflozin-
Run-in period: Placebo to empagliflozin 10 mgPlacebo to empagliflozin-
Treatment period: 10 mg empagliflozin + 3 mg BI 690517BI 690517-
Treatment period: 10 mg empagliflozin + 3 mg BI 690517Empagliflozin-
Treatment period: 10 mg empagliflozin + 10 mg BI 690517BI 690517-
Treatment period: 10 mg empagliflozin + 10 mg BI 690517Empagliflozin-
Treatment period: 10 mg empagliflozin + 20 mg BI 690517BI 690517-
Treatment period: 10 mg empagliflozin + 20 mg BI 690517Empagliflozin-
Treatment period: 10 mg empagliflozin + Placebo to BI 690517Placebo to BI 690517-
Treatment period: 10 mg empagliflozin + Placebo to BI 690517Empagliflozin-
Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517Placebo to empagliflozin-
Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517Placebo to empagliflozin-
Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517Placebo to empagliflozin-
Primary Outcome Measures
NameTimeMethod
Change From Treatment Period Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void (FMV) Urine After 14 Weeks - All PatientsThe MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

The adjusted mean change (95% confidence interval) in log transformed FMV UACR from baseline at 14 weeks is presented.

The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - All PatientsThe MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for all patients is presented.

Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)\*100/(FMV UACR at baseline).

MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching EmpagliflozinThe MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

The adjusted mean change (95% confidence interval) in log transformed first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline at 14 weeks for patients with background therapy of placebo matching empagliflozin in the Run-in period is presented.

The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - Patients With Background Therapy of Placebo Matching EmpagliflozinThe MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for patients with background therapy of placebo matching empagliflozin in the Run-in period is presented.

Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)\*100/(FMV UACR at baseline).

MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of EmpagliflozinThe MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

The adjusted mean change (95% confidence interval) in log transformed first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline at 14 weeks for patients with background therapy of empagliflozin in the Run-in period is presented.

The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) of MMRM Estimate - Patients With Background Therapy of EmpagliflozinThe MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.

Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for patients with background therapy of empagliflozin in the Run-in period is presented.

Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)\*100/(FMV UACR at baseline).

MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.

Secondary Outcome Measures
NameTimeMethod
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Multiple ImputationUACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-ResponderAt baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

The missing as non-responder imputes patients with missing Week 14 data as non-responders.

UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Week - All Patients - Last Observation on Treatment Carried Forward (LOCF)UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case AnalysisAt baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

Complete case analysis used patients with both baseline and Week 14 data available.

UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple ImputationUACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-ResponderAt baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

The missing as non-responder imputes patients with missing Week 14 data as non-responders.

UACR Response I, Defined as Decrease of at Least 30% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF)UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void (FMV) urine of UACR from treatment period baseline to 14 weeks.

LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case AnalysisAt baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

Complete case analysis used patients with both baseline and Week 14 data available.

UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple ImputationUACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-ResponderAt baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

The missing as non-responder imputes patients with missing Week 14 data as non-responders.

UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried ForwardUACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

Last observation on treatment carried forward (LOCF) uses the last value observed on treatment to substitute all missing values until Week 14.

UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case AnalysisAt baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

Complete case analysis used patients with both baseline and Week 14 data available.

UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients -Multiple ImputationUACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 week. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-ResponderAt baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

The missing as non-responder imputes patients with missing Week 14 data as non-responders.

UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Last Observation on Treatment Carried Forward (LOCF)UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case AnalysisAt baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

Complete case analysis used patients with both baseline and Week 14 data available.

UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple ImputationUACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-ResponderAt baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

The missing as non-responder imputes patients with missing Week 14 data as non-responders.

UACR Response II, Defined as Decrease of at Least 15% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF)UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void (FMV) urine of UACR from treatment period baseline to 14 weeks.

LOCF uses the last value observed on treatment to substitute all missing values until Week 14.

UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple ImputationUACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.

Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.

UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-ResponderAt baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

The missing as non-responder imputes patients with missing Week 14 data as non-responders.

UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried ForwardUACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.

Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

Last observation on treatment carried forward (LOCF) uses the last value observed on treatment to substitute all missing values until Week 14.

UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks -Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case AnalysisAt baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

Complete case analysis used patients with both baseline and Week 14 data available.

UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case AnalysisAt baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.

Complete case analysis used patients with both baseline and Week 14 data available.

Trial Locations

Locations (202)

Toronto General Hospital

🇨🇦

Toronto, Ontario, Canada

Cleveland Clinic

🇺🇸

Cleveland, Ohio, United States

PrimeCare Medical Group

🇺🇸

Houston, Texas, United States

Suwa Red Cross Hospital

🇯🇵

Nagano, Suwa, Japan

Miho Clinic

🇯🇵

Tokyo, Shinagawa-ku, Japan

Robert Koch Clinic Sofia

🇧🇬

Sofia, Bulgaria

Recherche GCP Research

🇨🇦

Montreal, Quebec, Canada

Centro de Pesquisa Clinica - CPCLIN

🇧🇷

Sao Paulo, Brazil

The Bailey Clinic

🇨🇦

Red Deer, Alberta, Canada

Shivinder Jolly, Nephrologist

🇨🇦

Waterloo, Ontario, Canada

BR Trials

🇧🇷

Sao Paulo, Brazil

Sameh Fikry Medicine Professional Corporation

🇨🇦

Waterloo, Ontario, Canada

Citydiabetes, Stockholm

🇸🇪

Stockholm, Sweden

Istanbul University

🇹🇷

Istanbul, Turkey

Hospital do RIM - UNIFESP

🇧🇷

São Paulo, Brazil

Meitetsu Hospital

🇯🇵

Aichi, Nagoya, Japan

Clearview Medical Research, LLC

🇺🇸

Canyon Country, California, United States

A.O. Policlinico Giovanni XXIII di Bari

🇮🇹

Bari, Italy

ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII

🇮🇹

Bergamo, Italy

TOSAKI Clinic for Diabetes and Endocrinology

🇯🇵

Aichi, Nagoya, Japan

MILAN KVAPIL s.r.o.

🇨🇿

Pribram, Czechia

Omihachiman Community Medical Center

🇯🇵

Shiga, Omihachiman, Japan

Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen

🇩🇪

Bad Oeynhausen, Germany

Nagoya Kyoritsu Hospital

🇯🇵

Aichi, Nagoya, Japan

Cardiologicum Dresden und Pirna

🇩🇪

Dresden, Germany

Universitätsklinikum Carl Gustav Carus Dresden

🇩🇪

Dresden, Germany

DRC Drug Research Ltd

🇭🇺

Balatonfured, Hungary

National Hospital Organization Takasaki General Medical Center

🇯🇵

Gumma, Takasaki, Japan

Kyoto Okamoto Memorial Hospital

🇯🇵

Kyoto, Kuse-gun, Japan

Inje University Ilsan Paik Hospital

🇰🇷

Goyang, Korea, Republic of

Medizinische Hochschule Hannover

🇩🇪

Hannover, Germany

Iatros International

🇿🇦

Bloemfontein, South Africa

General Hospital of Athens "Laiko"

🇬🇷

Athens, Greece

Yamaura Medical Clinic

🇯🇵

Ueda, Nagano, Japan

Daiyukai Clinic

🇯🇵

Aichi, Ichinomiya, Japan

Asano Clinic

🇯🇵

Saitama, Kawagoe, Japan

Universitätsklinikum Würzburg AÖR

🇩🇪

Würzburg, Germany

Synexus Clinical Research GmbH

🇩🇪

Leipzig, Germany

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

Severance Hospital

🇰🇷

Seoul, Korea, Republic of

Tokyo Medical University Hachioji Medical Center

🇯🇵

Tokyo, Hachioji, Japan

SMG-SNU Boramae Medical Center

🇰🇷

Seoul, Korea, Republic of

Synexus Helderberg Clinical Research Centre

🇿🇦

Cape Town, South Africa

Latiff, GHVM

🇿🇦

Durban, South Africa

DJW Navorsing

🇿🇦

Krugersdorp, South Africa

Centralsjukhuset, Kristianstad

🇸🇪

Kristianstad, Sweden

Elixia Upland, LLC

🇺🇸

Upland, Pennsylvania, United States

CEDIC - Centro de Investigacion Clinica

🇦🇷

Caba, Argentina

Fundación Jiménez Díaz

🇪🇸

Madrid, Spain

Paarl Research Centre

🇿🇦

Cape Town, South Africa

Synexus Watermeyer Clinical Research Centre

🇿🇦

Pretoria, South Africa

Diabetes & Endocrinology Associates of Stark County

🇺🇸

Canton, Ohio, United States

Universal Research Group, LLC

🇺🇸

Tacoma, Washington, United States

West Orange Endocrinology

🇺🇸

Ocoee, Florida, United States

Universitetssjukhuset, Linköping

🇸🇪

Linköping, Sweden

Hospital Vall d'Hebron

🇪🇸

Barcelona, Spain

Knoxville Kidney Center PLLC

🇺🇸

Knoxville, Tennessee, United States

Hospital Puerta de Hierro

🇪🇸

Majadahonda, Spain

TREAD Research

🇿🇦

Cape Town, South Africa

Langeberg Clinical Trials

🇿🇦

Cape Town, South Africa

University Hospital of Lausanne

🇨🇭

Lausanne, Switzerland

Monument Health

🇺🇸

Rapid City, South Dakota, United States

Pacific Renal Associates

🇺🇸

Long Beach, California, United States

Horizon Research Group

🇺🇸

Coral Gables, Florida, United States

Academy Of Diabetes, Thyroid And Endocrine, PA

🇺🇸

El Paso, Texas, United States

Valley Clinical Trials, Inc.

🇺🇸

Northridge, California, United States

Hospital Público Da Mariña

🇪🇸

Burela, Spain

Triad Internal Medicine

🇺🇸

Asheboro, North Carolina, United States

Aa Mrc Llc

🇺🇸

Flint, Michigan, United States

Lucas Research, Inc.

🇺🇸

Morehead City, North Carolina, United States

CIMEL centro de Investigaciones Médicas Lanús

🇦🇷

Buenos Aires, Argentina

Amicis Research Center

🇺🇸

Northridge, California, United States

Providence Medical Research Center

🇺🇸

Spokane, Washington, United States

Aventiv Research Inc.

🇺🇸

Mesa, Arizona, United States

Simcare Medical Research, LLC

🇺🇸

Sugar Land, Texas, United States

Elixia Fort Lauderdale, LLC

🇺🇸

Fort Lauderdale, Florida, United States

South Florida Research Institute

🇺🇸

Lauderdale Lakes, Florida, United States

Glenny Corp. S.A. Bioclinica Argentina

🇦🇷

Ciudad Autonoma Buenos Aires, Argentina

Elixia Tampa, LLC

🇺🇸

Temple Terrace, Florida, United States

Hospital Universitario Reina Sofía

🇪🇸

Córdoba, Spain

Pines Care Research Center

🇺🇸

Pembroke Pines, Florida, United States

Kansas Nephrology Research Institute, LLC

🇺🇸

Wichita, Kansas, United States

Research Institute of Dallas

🇺🇸

Dallas, Texas, United States

Monash University

🇦🇺

Box Hill, Victoria, Australia

Cedar Crosse Research Center

🇺🇸

Chicago, Illinois, United States

Instituto Privado de Investigaciones Clínica Córdoba S.A.

🇦🇷

Cordoba, Argentina

John Hunter Hospital

🇦🇺

New Lambton Heights, New South Wales, Australia

Centro de Salud Renal Junín

🇦🇷

Junín, Argentina

San Marcus Research Clinic, Inc.

🇺🇸

Miami, Florida, United States

Total Research Group, LLC

🇺🇸

Miami, Florida, United States

Horizon Research Group, LLC

🇺🇸

Miami, Florida, United States

Guangdong Provincial People's Hospital

🇨🇳

Guangzhou, China

The First Afiliated Hospital, Sun Yet-sen University

🇨🇳

Guangzhou, China

Zhejiang Province People's Hospital

🇨🇳

Hangzhou, China

Huashan Hospital, Fudan University

🇨🇳

Shanghai, China

Shanghai Fifth People's Hospital affiliated to Fudan University

🇨🇳

Shanghai, China

Medical Center Rusemed

🇧🇬

Ruse, Bulgaria

Tampere University Hospital

🇫🇮

Tampere, Finland

MHAT Prof Stoyan Kirkovich AD

🇧🇬

Stara Zagora, Bulgaria

Markhot Ferenc Hospital, Eger

🇭🇺

Eger, Hungary

SMS Medical College and HospitaL

🇮🇳

Jaipur, India

All India Institute of Medical Sciences

🇮🇳

New Delhi, India

Shree Giriraj Multispeciality Hospital

🇮🇳

Rajkot, India

Government Medical College & Hospital

🇮🇳

Aurangabad, India

Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

🇲🇽

Mexico, Mexico

Clinstile S.A. de C.V.

🇲🇽

México, Mexico

CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc

🇲🇽

México, Mexico

Davao Doctors Hospital

🇵🇭

Davao City, Philippines

Philippine Heart Center

🇵🇭

Quezon City, Philippines

NZOZ Specialized Ambulance "MEDICA"

🇵🇱

Lublin, Poland

Charleroi - UNIV CHU de Charleroi

🇧🇪

Lodelinsart, Belgium

Medical Center Synexus Sofia EOOD

🇧🇬

Sofia, Bulgaria

"Attiko" Hospital of Athens

🇬🇷

Athens, Greece

Univ. Gen. Hosp. of Ioannina

🇬🇷

Ioannina, Greece

Semmelweis University

🇭🇺

Budapest, Hungary

Synexus Hungary Healthcare Service Ltd.

🇭🇺

Budapest, Hungary

Satucon Oy

🇫🇮

Kuopio, Finland

Lausmed Kft. Outpatient Unit of Internal Medicine

🇭🇺

Baja, Hungary

BKS Research Ltd

🇭🇺

Hatvan, Hungary

Ganesh Shankar Vidyarthi Memorial Medical College

🇮🇳

Kanpur, India

Tuanku Fauziah Hospital

🇲🇾

Kangar, Malaysia

Unidad de Investigación Clinica y Atencion Medica HEPA SC

🇲🇽

Guadalajara, Mexico

Akershus Universitetssykehus HF

🇳🇴

Nordbyhagen, Norway

Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice

🇵🇱

Katowice, Poland

Omedica Medical Centre, Poznan

🇵🇱

Poznan, Poland

Synexus Poland, Branch in Poznan

🇵🇱

Poznan, Poland

Barwijuk Clinics

🇵🇱

Warszawa, Poland

Jaipur National University Institute for Medical Science & Research Centre

🇮🇳

Jaipur, India

K R Hospital Mysore Medical College and Research Centre

🇮🇳

Mysore, India

Galaxy Lifecare Services Pvt. Ltd.

🇮🇳

Varanasi, India

Christian Medical College

🇮🇳

Vellore, India

Hospital Raja Perempuan Zainab II, Kota Bharu

🇲🇾

Kota Bharu, Malaysia

Hospital Seri Manjung

🇲🇾

Seri Manjung, Malaysia

Centro Mexicano de Desarrollo de Estudios Clínicos SA -CEMDEC

🇲🇽

Mexico, Mexico

INTERCORE Medical Center

🇵🇱

Bydgoszcz, Poland

Pro Familia Altera

🇵🇱

Katowice, Poland

Hospitals of Tczew S.A.

🇵🇱

Pomorskie, Poland

Medical Center HCP Sp. z o.o

🇵🇱

Poznan, Poland

Kingsway Hospitals

🇮🇳

Nagpur, India

West Visayas State University Medical Center

🇵🇭

Iloilo City, Philippines

Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk

🇵🇱

Gdansk, Poland

Synexus Lodz Medical Center

🇵🇱

Lodz, Poland

Synexus Poland, Branch in Wroclaw

🇵🇱

Wroclaw, Poland

ULS de Almada -Seixal, E. P. E. - Hospital Garcia de Orta

🇵🇹

Almada, Portugal

ULS da Região de Aveiro

🇵🇹

Aveiro, Portugal

Brussels - UNIV UZ Brussel

🇧🇪

Brussel, Belgium

Brussels - UNIV Saint-Luc

🇧🇪

Bruxelles, Belgium

St Vincent's Hospital Melbourne

🇦🇺

Fitzroy, Victoria, Australia

Hospital Selayang

🇲🇾

Batu Caves, Malaysia

University Kebangsaan Malaysia

🇲🇾

Cheras, Kuala Lumpur, Malaysia

Hospital Universitario Dr Jose Eleuterio Gonzalez

🇲🇽

Nuevo León, Mexico

Helse Stavanger, Stavanger Universitetssykehus

🇳🇴

Stavanger, Norway

Norzel Medical and Diagnostic Clinic

🇵🇭

Cebu City, Philippines

The Medical City

🇵🇭

Pasig City, Philippines

Senor Santo Nino Hospital

🇵🇭

Tarlac, Philippines

ULS da Região de Leiria, E.P.E.

🇵🇹

Leiria, Portugal

ULS de Gaia/Espinho, EPE

🇵🇹

Vila Nova de Gaia, Portugal

Centrum Medyczne Synexus

🇵🇱

Warszawa, Poland

CHLO, EPE - Hospital de Santa Cruz

🇵🇹

Carnaxide, Portugal

La Louvière - UNIV CHU Tivoli

🇧🇪

La Louvière, Belgium

Forte Family Practice

🇺🇸

Las Vegas, Nevada, United States

AKDHC Medical Research Services, LLC

🇺🇸

Phoenix, Arizona, United States

Colorado Kidney Care

🇺🇸

Denver, Colorado, United States

Ina Central Hospital

🇯🇵

Nagano, Ina, Japan

The University of Tokyo Hospital

🇯🇵

Tokyo, Bunkyo-ku, Japan

DaVita Clinical Research Germany GmbH

🇩🇪

Düsseldorf, Germany

California Kidney Specialists

🇺🇸

San Dimas, California, United States

Hospital Universitário João de Barros Barreto

🇧🇷

Belém, Brazil

UZ Leuven

🇧🇪

Leuven/Vlaams-Brabant, Belgium

Ruschel Medicina e Pesquisa Clínica

🇧🇷

Rio de Janeiro, Brazil

Fundação Pró Renal Brasil

🇧🇷

Curitiba, Brazil

Faculdade de Medicina de Botucatu - UNESP

🇧🇷

Botucatu, Brazil

CEMEC - Centro Multidisciplinar de Estudos Clínicos

🇧🇷

São Bernardo do Campo, Brazil

Universidade Federal do Rio Grande do Sul

🇧🇷

Porto Alegre, Brazil

LMC Clinical Research Inc. (Brampton)

🇨🇦

Brampton, Ontario, Canada

The First People's Hospital of Nanning

🇨🇳

Nanning, China

DIKa centrum s.r.o.

🇨🇿

Havirov, Czechia

Synexus Czech s.r.o.

🇨🇿

Prague, Czechia

Hospital Slany, Internal Department

🇨🇿

Slany, Czechia

Turku University Hospital / TYKS

🇫🇮

Turku, Finland

Institut für klinische Forschung und Entwicklung (IKFE) Berlin GmbH

🇩🇪

Berlin, Germany

Iatriko of Athens Group/ Iatriko of P. Faliro

🇬🇷

P. Faliro, Greece

University Debrecen Hospital

🇭🇺

Debrecen, Hungary

Korea University Ansan Hospital

🇰🇷

Ansan, Korea, Republic of

Klinik Kesihatan Mahmoodiah

🇲🇾

Johor Bahru, Malaysia

Chungbuk National University Hospital

🇰🇷

Cheongiu, Korea, Republic of

Centro de Investigacion Cardiometabolica de Aguascalientes

🇲🇽

Aguascalientes, Mexico

Institute for Studies on Diabetes Foundation Inc.

🇵🇭

Marikina city, Philippines

Clinical Best Solutions

🇵🇱

Lublin, Poland

APDP - Associação Protectora dos Diabéticos de Portugal

🇵🇹

Lisboa, Portugal

Elite Research Center, LLC

🇺🇸

Flint, Michigan, United States

New Mexico Clinical Research and Osteoporosis Center, Inc.

🇺🇸

Albuquerque, New Mexico, United States

Heritage Valley Medical Group

🇺🇸

Beaver, Pennsylvania, United States

P&I Clinical Research, LLC

🇺🇸

Lufkin, Texas, United States

Centro de Investigaciones Médicas Mar del Plata

🇦🇷

Mar del Plata, Argentina

CEMEDIC - Centro de Especialidades Medicas

🇦🇷

Villa Luro, Argentina

Instituto Médico Catamarca - IMEC

🇦🇷

Rosario, Argentina

Boise Kidney and Hypertension PLLC

🇺🇸

Nampa, Idaho, United States

Clinical Research Consultants, LLC

🇺🇸

Kansas City, Missouri, United States

Clinical Research of Brandon LLC

🇺🇸

Brandon, Florida, United States

Prince of Wales Hospital

🇭🇰

Hong Kong, Hong Kong

Queen Mary Hospital

🇭🇰

Hong Kong, Hong Kong

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