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

NCT05182840 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 1378.52021-001434-191378-0005
• Study Type: interventional
• Target: 714
• Locations: 29 countries
• Sites: 203

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.

Conditions

Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (6)

• Change From Treatment Period Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void (FMV) Urine After 14 Weeks - All Patients

  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.

  The 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 FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - All Patients

  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.

  The 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.

• Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching Empagliflozin

  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.

  The 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 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 Empagliflozin

  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.

  The 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.

• Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Empagliflozin

  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.

  The 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 FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) of MMRM Estimate - Patients With Background Therapy of Empagliflozin

  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.

  The 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.

Secondary Outcomes (24)

• 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 Imputation

  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 multiple imputation approach.

• 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-Responder

  At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

• 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.

• 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 Analysis

  At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.

• 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 Imputation

  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 multiple imputation approach.

Study Arms (10)

Run-in period: 10 mg empagliflozin

EXPERIMENTAL

Drug: Empagliflozin

Run-in period: Placebo to empagliflozin 10 mg

PLACEBO COMPARATOR

Drug: Placebo to empagliflozin

Treatment period: 10 mg empagliflozin + 3 mg BI 690517

EXPERIMENTAL

Drug: BI 690517; Drug: Empagliflozin

Treatment period: 10 mg empagliflozin + 10 mg BI 690517

EXPERIMENTAL

Drug: BI 690517; Drug: Empagliflozin

Treatment period: 10 mg empagliflozin + 20 mg BI 690517

EXPERIMENTAL

Drug: BI 690517; Drug: Empagliflozin

Treatment period: 10 mg empagliflozin + Placebo to BI 690517

PLACEBO COMPARATOR

Drug: Placebo to BI 690517; Drug: Empagliflozin

Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517

EXPERIMENTAL

Drug: BI 690517; Drug: Placebo to empagliflozin

Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517

EXPERIMENTAL

Drug: BI 690517; Drug: Placebo to empagliflozin

Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517

EXPERIMENTAL

Drug: BI 690517; Drug: Placebo to empagliflozin

Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517

PLACEBO COMPARATOR

Drug: Placebo to BI 690517; Drug: Placebo to empagliflozin

Interventions

BI 690517 DRUG

Film-coated tablets

Also known as: Vicadrostat

Treatment period: 10 mg empagliflozin + 10 mg BI 690517; Treatment period: 10 mg empagliflozin + 20 mg BI 690517; Treatment period: 10 mg empagliflozin + 3 mg BI 690517; Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517; Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517; Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517

Placebo to BI 690517 DRUG

Film-coated tablets

Treatment period: 10 mg empagliflozin + Placebo to BI 690517; Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517

Empagliflozin DRUG

Empagliflozin

Run-in period: 10 mg empagliflozin; Treatment period: 10 mg empagliflozin + 10 mg BI 690517; Treatment period: 10 mg empagliflozin + 20 mg BI 690517; Treatment period: 10 mg empagliflozin + 3 mg BI 690517; Treatment period: 10 mg empagliflozin + Placebo to BI 690517

Placebo to empagliflozin DRUG

Placebo to empagliflozin

Run-in period: Placebo to empagliflozin 10 mg; Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517; Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517; Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517; Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (203)

Aventiv Research Inc.

Mesa, Arizona, 85206, United States

Location

AKDHC Medical Research Services, LLC

Phoenix, Arizona, 85027, United States

Location

Clearview Medical Research, LLC

Canyon Country, California, 91351, United States

Location

Pacific Renal Associates

Long Beach, California, 90806, United States

Location

Amicis Research Center

Northridge, California, 91324, United States

Location

Valley Clinical Trials, Inc.

Northridge, California, 91325, United States

Location

California Kidney Specialists

San Dimas, California, 91773, United States

Location

Colorado Kidney Care

Denver, Colorado, 80230, United States

Location

Clinical Research of Brandon LLC

Brandon, Florida, 33511, United States

Location

Horizon Research Group

Coral Gables, Florida, 33134, United States

Location

Elixia Fort Lauderdale, LLC

Fort Lauderdale, Florida, 33308, United States

Location

South Florida Research Institute

Lauderdale Lakes, Florida, 33313, United States

Location

San Marcus Research Clinic, Inc.

Miami, Florida, 33014, United States

Location

Total Research Group, LLC

Miami, Florida, 33126, United States

Location

Horizon Research Group, LLC

Miami, Florida, 33150, United States

Location

West Orange Endocrinology

Ocoee, Florida, 34761, United States

Location

Pines Care Research Center

Pembroke Pines, Florida, 33024, United States

Location

Elixia Tampa, LLC

Temple Terrace, Florida, 33637, United States

Location

Boise Kidney and Hypertension PLLC

Nampa, Idaho, 83687, United States

Location

Cedar Crosse Research Center

Chicago, Illinois, 60607, United States

Location

Kansas Nephrology Research Institute, LLC

Wichita, Kansas, 67214, United States

Location

Aa Mrc Llc

Flint, Michigan, 48504, United States

Location

Elite Research Center, LLC

Flint, Michigan, 48532, United States

Location

Clinical Research Consultants, LLC

Kansas City, Missouri, 64111, United States

Location

Forte Family Practice

Las Vegas, Nevada, 89103, United States

Location

New Mexico Clinical Research and Osteoporosis Center, Inc.

Albuquerque, New Mexico, 87106, United States

Location

Triad Internal Medicine

Asheboro, North Carolina, 27203, United States

Location

Lucas Research, Inc.

Morehead City, North Carolina, 28557, United States

Location

Diabetes & Endocrinology Associates of Stark County

Canton, Ohio, 44718, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Heritage Valley Medical Group

Beaver, Pennsylvania, 15009, United States

Location

Elixia Upland, LLC

Upland, Pennsylvania, 19013, United States

Location

Monument Health

Rapid City, South Dakota, 57701, United States

Location

Knoxville Kidney Center PLLC

Knoxville, Tennessee, 37923, United States

Location

Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

Academy Of Diabetes, Thyroid And Endocrine, PA

El Paso, Texas, 79935, United States

Location

PrimeCare Medical Group

Houston, Texas, 77024, United States

Location

P&I Clinical Research, LLC

Lufkin, Texas, 75904, United States

Location

Simcare Medical Research, LLC

Sugar Land, Texas, 77478, United States

Location

Providence Medical Research Center

Spokane, Washington, 99204, United States

Location

Universal Research Group, LLC

Tacoma, Washington, 98405, United States

Location

CIMEL centro de Investigaciones Médicas Lanús

Buenos Aires, B1824KAJ, Argentina

Location

CEDIC - Centro de Investigacion Clinica

CABA, C1060ABN, Argentina

Location

Glenny Corp. S.A. Bioclinica Argentina

Ciudad Autonoma Buenos Aires, C1430CKE, Argentina

Location

Instituto Privado de Investigaciones Clínica Córdoba S.A.

Córdoba, X5000AAW, Argentina

Location

Centro de Salud Renal Junín

Junín, B6000GMA, Argentina

Location

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, B7600FYK, Argentina

Location

Instituto Médico Catamarca - IMEC

Rosario, S2000AJU, Argentina

Location

CEMEDIC - Centro de Especialidades Medicas

Villa Luro, C1440CFD, Argentina

Location

John Hunter Hospital

New Lambton Heights, New South Wales, 2305, Australia

Location

Monash University

Box Hill, Victoria, 3128, Australia

Location

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Brussels - UNIV UZ Brussel

Brussels, 1090, Belgium

Location

Brussels - UNIV Saint-Luc

Brussels, 1200, Belgium

Location

La Louvière - UNIV CHU Tivoli

La Louvière, 7100, Belgium

Location

UZ Leuven

Leuven/Vlaams-Brabant, 3000, Belgium

Location

Charleroi - UNIV CHU de Charleroi

Lodelinsart, 6042, Belgium

Location

Hospital Universitário João de Barros Barreto

Belém, CEP 66073-, Brazil

Location

Faculdade de Medicina de Botucatu - UNESP

Botucatu, 18618-687, Brazil

Location

Fundação Pró Renal Brasil

Curitiba, 80440-020, Brazil

Location

Universidade Federal do Rio Grande do Sul

Porto Alegre, 90430-001, Brazil

Location

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, 22270-060, Brazil

Location

CEMEC - Centro Multidisciplinar de Estudos Clínicos

São Bernardo do Campo, 09780-000, Brazil

Location

BR Trials

São Paulo, 01236-030, Brazil

Location

Centro de Pesquisa Clinica - CPCLIN

São Paulo, 01244-030, Brazil

Location

Hospital do RIM - UNIFESP

São Paulo, 04023-062, Brazil

Location

Medical Center Rusemed

Rousse, 7013, Bulgaria

Location

Robert Koch Clinic Sofia

Sofia, 1407, Bulgaria

Location

Medical Center Synexus Sofia EOOD

Sofia, 1784, Bulgaria

Location

MHAT Prof Stoyan Kirkovich AD

Stara Zagora, 6000, Bulgaria

Location

The Bailey Clinic

Red Deer, Alberta, T4N 6V7, Canada

Location

LMC Clinical Research Inc. (Brampton)

Brampton, Ontario, L6S 0C6, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Sameh Fikry Medicine Professional Corporation

Waterloo, Ontario, N2J 1C4, Canada

Location

Shivinder Jolly, Nephrologist

Waterloo, Ontario, N2T 0C1, Canada

Location

Recherche GCP Research

Montreal, Quebec, H1M 1B1, Canada

Location

Guangdong Provincial People's Hospital

Guangzhou, 510080, China

Location

The First Afiliated Hospital, Sun Yet-sen University

Guangzhou, 510080, China

Location

Zhejiang Province People's Hospital

Hangzhou, 310014, China

Location

The First People's Hospital of Nanning

Nanning, 530000, China

Location

Huashan Hospital, Fudan University

Shanghai, 200040, China

Location

Shanghai Fifth People's Hospital affiliated to Fudan University

Shanghai, 200240, China

Location

DIKa centrum s.r.o.

Havířov, 73601, Czechia

Location

Synexus Czech s.r.o.

Prague, 120 00, Czechia

Location

MILAN KVAPIL s.r.o.

Příbram, 26101, Czechia

Location

Hospital Slany, Internal Department

Slaný, 274 01, Czechia

Location

Satucon Oy

Kuopio, 70100, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Turku University Hospital / TYKS

Turku, 20520, Finland

Location

Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen

Bad Oeynhausen, 32545, Germany

Location

Institut für klinische Forschung und Entwicklung (IKFE) Berlin GmbH

Berlin, 10437, Germany

Location

Cardiologicum Dresden und Pirna

Dresden, 01277, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

DaVita Clinical Research Germany GmbH

Düsseldorf, 40210, Germany

Location

Synexus Clinical Research GmbH

Frankfurt, 60313, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Synexus Clinical Research GmbH

Leipzig, 04103, Germany

Location

Universitätsklinikum Würzburg AÖR

Würzburg, 97080, Germany

Location

General Hospital of Athens "Laiko"

Athens, 115 27, Greece

Location

"Attiko" Hospital of Athens

Athens, 124 62, Greece

Location

Univ. Gen. Hosp. of Ioannina

Ioannina, 455 00, Greece

Location

Iatriko of Athens Group/ Iatriko of P. Faliro

P. Faliro, 17562, Greece

Location

Prince of Wales Hospital

Hong Kong, 999077, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Lausmed Kft. Outpatient Unit of Internal Medicine

Baja, 6500, Hungary

Location

DRC Drug Research Ltd

Balatonfüred, 8230, Hungary

Location

Synexus Hungary Healthcare Service Ltd.

Budapest, 1036, Hungary

Location

Semmelweis University

Budapest, 1083, Hungary

Location

University Debrecen Hospital

Debrecen, 4032, Hungary

Location

Markhot Ferenc Hospital, Eger

Eger, 3300, Hungary

Location

BKS Research Ltd

Hatvan, 3000, Hungary

Location

Government Medical College & Hospital

Aurangabad, 431001, India

Location

SMS Medical College and HospitaL

Jaipur, 302001, India

Location

Jaipur National University Institute for Medical Science & Research Centre

Jaipur, 302017, India

Location

Ganesh Shankar Vidyarthi Memorial Medical College

Kanpur, 208002, India

Location

K R Hospital Mysore Medical College and Research Centre

Mysore, 570001, India

Location

Kingsway Hospitals

Nagpur, 440001, India

Location

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

Shree Giriraj Multispeciality Hospital

Rajkot, 360005, India

Location

Galaxy Lifecare Services Pvt. Ltd.

Varanasi, 221010, India

Location

Christian Medical College

Vellore, 632004, India

Location

A.O. Policlinico Giovanni XXIII di Bari

Bari, 70124, Italy

Location

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

Bergamo, 24127, Italy

Location

Daiyukai Clinic

Aichi, Ichinomiya, 491-8551, Japan

Location

Meitetsu Hospital

Aichi, Nagoya, 451-8511, Japan

Location

Nagoya Kyoritsu Hospital

Aichi, Nagoya, 454-0933, Japan

Location

TOSAKI Clinic for Diabetes and Endocrinology

Aichi, Nagoya, 468-0009, Japan

Location

National Hospital Organization Takasaki General Medical Center

Gumma, Takasaki, 370-0829, Japan

Location

Kyoto Okamoto Memorial Hospital

Kyoto, Kuse-gun, 613-0034, Japan

Location

Ina Central Hospital

Nagano, Ina, 396-8555, Japan

Location

Suwa Red Cross Hospital

Nagano, Suwa, 392-8510, Japan

Location

Asano Clinic

Saitama, Kawagoe, 350-0851, Japan

Location

Omihachiman Community Medical Center

Shiga, Omihachiman, 523-0082, Japan

Location

The University of Tokyo Hospital

Tokyo, Bunkyo-ku, 113-8655, Japan

Location

Tokyo Medical University Hachioji Medical Center

Tokyo, Hachioji, 193-0998, Japan

Location

Miho Clinic

Tokyo, Shinagawa-ku, 141-0032, Japan

Location

Yamaura Medical Clinic

Ueda, Nagano, 386-0407, Japan

Location

Hospital Selayang

Batu Caves, 68100, Malaysia

Location

University Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Klinik Kesihatan Mahmoodiah

Johor Bahru, 80100, Malaysia

Location

Tuanku Fauziah Hospital

Kangar, 01000, Malaysia

Location

Hospital Raja Perempuan Zainab II, Kota Bharu

Kota Bharu, 15200, Malaysia

Location

Hospital Seri Manjung

Seri Manjung, 32040, Malaysia

Location

Centro de Investigacion Cardiometabolica de Aguascalientes

Aguascalientes, 20230, Mexico

Location

Unidad de Investigación Clinica y Atencion Medica HEPA SC

Guadalajara, 44670, Mexico

Location

Centro Mexicano de Desarrollo de Estudios Clínicos SA -CEMDEC

México, 06100, Mexico

Location

Clinstile S.A. de C.V.

México, 06700, Mexico

Location

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

México, 11650, Mexico

Location

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

México, 20010, Mexico

Location

Hospital Universitario Dr Jose Eleuterio Gonzalez

Nuevo León, 64460, Mexico

Location

Akershus Universitetssykehus HF

Nordbyhagen, 1478, Norway

Location

Helse Stavanger, Stavanger Universitetssykehus

Stavanger, 4011, Norway

Location

Norzel Medical and Diagnostic Clinic

Cebu City, 6000, Philippines

Location

Davao Doctors Hospital

Davao City, 8000, Philippines

Location

West Visayas State University Medical Center

Iloilo City, 5000, Philippines

Location

Institute for Studies on Diabetes Foundation Inc.

Marikina City, 1810, Philippines

Location

The Medical City

Pasig, 1605, Philippines

Location

Philippine Heart Center

Quezon City, 850, Philippines

Location

Senor Santo Nino Hospital

Tarlac City, 2306, Philippines

Location

INTERCORE Medical Center

Bydgoszcz, 85-605, Poland

Location

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

Gdansk, 80-382, Poland

Location

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

Katowice, 40-040, Poland

Location

Pro Familia Altera

Katowice, 40-648, Poland

Location

Synexus Lodz Medical Center

Lodz, 90127, Poland

Location

Clinical Best Solutions

Lublin, 20-078, Poland

Location

NZOZ Specialized Ambulance "MEDICA"

Lublin, 20-538, Poland

Location

Hospitals of Tczew S.A.

Pomorskie, 83-110, Poland

Location

Omedica Medical Centre, Poznan

Poznan, 60-111, Poland

Location

Synexus Poland, Branch in Poznan

Poznan, 60-702, Poland

Location

Medical Center HCP Sp. z o.o

Poznan, 61-485, Poland

Location

Centrum Medyczne Synexus

Warsaw, 02-672, Poland

Location

Barwijuk Clinics

Warsaw, 02-884, Poland

Location

Synexus Poland, Branch in Wroclaw

Wroclaw, 50-088, Poland

Location

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

Almada, 2801-951, Portugal

Location

ULS da Região de Aveiro

Aveiro, 3810-164, Portugal

Location

CHLO, EPE - Hospital de Santa Cruz

Carnaxide, 2790-134, Portugal

Location

ULS da Região de Leiria, E.P.E.

Leiria, 2410-197, Portugal

Location

APDP - Associação Protectora dos Diabéticos de Portugal

Lisbon, 1250-189, Portugal

Location

ULS de Gaia/Espinho, EPE

Vila Nova de Gaia, 4434-502, Portugal

Location

Iatros International

Bloemfontein, 9324, South Africa

Location

Synexus Helderberg Clinical Research Centre

Cape Town, 7130, South Africa

Location

TREAD Research

Cape Town, 7500, South Africa

Location

Langeberg Clinical Trials

Cape Town, 7570, South Africa

Location

Paarl Research Centre

Cape Town, 7646, South Africa

Location

Latiff, GHVM

Durban, 4001, South Africa

Location

DJW Navorsing

Krugersdorp, 1739, South Africa

Location

Synexus Watermeyer Clinical Research Centre

Pretoria, 0184, South Africa

Location

Korea University Ansan Hospital

Ansan, 15355, South Korea

Location

Chungbuk National University Hospital

Cheongiu, 28644, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang, 10380, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 156-707, South Korea

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Público Da Mariña

Burela de Cabo, 27880, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Puerta de Hierro

Majadahonda, 28222, Spain

Location

Centralsjukhuset, Kristianstad

Kristianstad, 291 33, Sweden

Location

Universitetssjukhuset, Linköping

Linköping, 581 85, Sweden

Location

Citydiabetes, Stockholm

Stockholm, 112 21, Sweden

Location

University Hospital of Lausanne

Lausanne, 1011, Switzerland

Location

Istanbul University

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (2)

• Gashaw IA, Tuttle KR, Monroy Kuhn M, Pleiner S, Delic D, Cronin L, Shah SV, Rossing P. Pharmacodynamics of vicadrostat for aldosterone synthase inhibition in patients with CKD. Eur J Endocrinol. 2026 Jan 6;194(1):46-57. doi: 10.1093/ejendo/lvaf265.

  PMID: 41436034 DERIVED

• Tuttle KR, Hauske SJ, Canziani ME, Caramori ML, Cherney D, Cronin L, Heerspink HJL, Hugo C, Nangaku M, Rotter RC, Silva A, Shah SV, Sun Z, Urbach D, de Zeeuw D, Rossing P; ASi in CKD group. Efficacy and safety of aldosterone synthase inhibition with and without empagliflozin for chronic kidney disease: a randomised, controlled, phase 2 trial. Lancet. 2024 Jan 27;403(10424):379-390. doi: 10.1016/S0140-6736(23)02408-X. Epub 2023 Dec 15.

  PMID: 38109916 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 10, 2022
• Study Start: January 11, 2022
• Primary Completion: June 19, 2023
• Study Completion: July 10, 2023
• Last Updated: October 22, 2024
• Results First Posted: August 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

FI (3); ME (7); US (41); DE (9); IT (2); AU (3); HK (2); MY (6); GR (4); NO (2); KR (6); CN (6); BU (4); HU (7); BR (9); CA (6); PL (14); TU (1); PH (7); ES (5); PT (6); AR (8); ZA (8); SE (3); CH (1); JP (14); BE (5); CZ (4); IN (10)