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

NCT ID: NCT05182840

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 714 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2023-07-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Run-in period: 10 mg empagliflozin

Group Type: EXPERIMENTAL

Empagliflozin

Intervention Type: DRUG

Empagliflozin

Run-in period: Placebo to empagliflozin 10 mg

Group Type: PLACEBO_COMPARATOR

Placebo to empagliflozin

Intervention Type: DRUG

Placebo to empagliflozin

Treatment period: 10 mg empagliflozin + 3 mg BI 690517

Group Type: EXPERIMENTAL

BI 690517

Intervention Type: DRUG

Film-coated tablets

Empagliflozin

Intervention Type: DRUG

Empagliflozin

Treatment period: 10 mg empagliflozin + 10 mg BI 690517

Group Type: EXPERIMENTAL

BI 690517

Intervention Type: DRUG

Film-coated tablets

Empagliflozin

Intervention Type: DRUG

Empagliflozin

Treatment period: 10 mg empagliflozin + 20 mg BI 690517

Group Type: EXPERIMENTAL

BI 690517

Intervention Type: DRUG

Film-coated tablets

Empagliflozin

Intervention Type: DRUG

Empagliflozin

Treatment period: 10 mg empagliflozin + Placebo to BI 690517

Group Type: PLACEBO_COMPARATOR

Placebo to BI 690517

Intervention Type: DRUG

Film-coated tablets

Empagliflozin

Intervention Type: DRUG

Empagliflozin

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

Group Type: EXPERIMENTAL

BI 690517

Intervention Type: DRUG

Film-coated tablets

Placebo to empagliflozin

Intervention Type: DRUG

Placebo to empagliflozin

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

Group Type: EXPERIMENTAL

BI 690517

Intervention Type: DRUG

Film-coated tablets

Placebo to empagliflozin

Intervention Type: DRUG

Placebo to empagliflozin

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

Group Type: EXPERIMENTAL

BI 690517

Intervention Type: DRUG

Film-coated tablets

Placebo to empagliflozin

Intervention Type: DRUG

Placebo to empagliflozin

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

Group Type: PLACEBO_COMPARATOR

Placebo to BI 690517

Intervention Type: DRUG

Film-coated tablets

Placebo to empagliflozin

Intervention Type: DRUG

Placebo to empagliflozin

Interventions

BI 690517

Film-coated tablets

Intervention Type: DRUG

Placebo to BI 690517

Film-coated tablets

Intervention Type: DRUG

Empagliflozin

Empagliflozin

Intervention Type: DRUG

Placebo to empagliflozin

Placebo to empagliflozin

Intervention Type: DRUG

Other Intervention Names

Vicadrostat

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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aventiv Research Inc.

Mesa, Arizona, United States

AKDHC Medical Research Services, LLC

Phoenix, Arizona, United States

Clearview Medical Research, LLC

Canyon Country, California, United States

Pacific Renal Associates

Long Beach, California, United States

Amicis Research Center

Northridge, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

California Kidney Specialists

San Dimas, California, United States

Colorado Kidney Care

Denver, Colorado, United States

Clinical Research of Brandon LLC

Brandon, Florida, United States

Horizon Research Group

Coral Gables, Florida, United States

Elixia Fort Lauderdale, LLC

Fort Lauderdale, Florida, United States

South Florida Research Institute

Lauderdale Lakes, Florida, United States

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

West Orange Endocrinology

Ocoee, Florida, United States

Pines Care Research Center

Pembroke Pines, Florida, United States

Elixia Tampa, LLC

Temple Terrace, Florida, United States

Boise Kidney and Hypertension PLLC

Nampa, Idaho, United States

Cedar Crosse Research Center

Chicago, Illinois, United States

Kansas Nephrology Research Institute, LLC

Wichita, Kansas, United States

Aa Mrc Llc

Flint, Michigan, United States

Elite Research Center, LLC

Flint, Michigan, United States

Clinical Research Consultants, LLC

Kansas City, Missouri, United States

Forte Family Practice

Las Vegas, Nevada, United States

New Mexico Clinical Research and Osteoporosis Center, Inc.

Albuquerque, New Mexico, United States

Triad Internal Medicine

Asheboro, North Carolina, United States

Lucas Research, Inc.

Morehead City, North Carolina, United States

Diabetes & Endocrinology Associates of Stark County

Canton, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Heritage Valley Medical Group

Beaver, Pennsylvania, United States

Elixia Upland, LLC

Upland, Pennsylvania, United States

Monument Health

Rapid City, South Dakota, United States

Knoxville Kidney Center PLLC

Knoxville, Tennessee, United States

Research Institute of Dallas

Dallas, Texas, United States

Academy Of Diabetes, Thyroid And Endocrine, PA

El Paso, Texas, United States

PrimeCare Medical Group

Houston, Texas, United States

P&I Clinical Research, LLC

Lufkin, Texas, United States

Simcare Medical Research, LLC

Sugar Land, Texas, United States

Providence Medical Research Center

Spokane, Washington, United States

Universal Research Group, LLC

Tacoma, Washington, United States

CIMEL centro de Investigaciones Médicas Lanús

Buenos Aires, , Argentina

CEDIC - Centro de Investigacion Clinica

CABA, , Argentina

Glenny Corp. S.A. Bioclinica Argentina

Ciudad Autonoma Buenos Aires, , Argentina

Instituto Privado de Investigaciones Clínica Córdoba S.A.

Córdoba, , Argentina

Centro de Salud Renal Junín

Junín, , Argentina

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, , Argentina

Instituto Médico Catamarca - IMEC

Rosario, , Argentina

CEMEDIC - Centro de Especialidades Medicas

Villa Luro, , Argentina

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Monash University

Box Hill, Victoria, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Brussels - UNIV UZ Brussel

Brussels, , Belgium

Brussels - UNIV Saint-Luc

Brussels, , Belgium

La Louvière - UNIV CHU Tivoli

La Louvière, , Belgium

UZ Leuven

Leuven/Vlaams-Brabant, , Belgium

Charleroi - UNIV CHU de Charleroi

Lodelinsart, , Belgium

Hospital Universitário João de Barros Barreto

Belém, , Brazil

Faculdade de Medicina de Botucatu - UNESP

Botucatu, , Brazil

Fundação Pró Renal Brasil

Curitiba, , Brazil

Universidade Federal do Rio Grande do Sul

Porto Alegre, , Brazil

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, , Brazil

CEMEC - Centro Multidisciplinar de Estudos Clínicos

São Bernardo do Campo, , Brazil

BR Trials

São Paulo, , Brazil

Centro de Pesquisa Clinica - CPCLIN

São Paulo, , Brazil

Hospital do RIM - UNIFESP

São Paulo, , Brazil

Medical Center Rusemed

Rousse, , Bulgaria

Robert Koch Clinic Sofia

Sofia, , Bulgaria

Medical Center Synexus Sofia EOOD

Sofia, , Bulgaria

MHAT Prof Stoyan Kirkovich AD

Stara Zagora, , Bulgaria

The Bailey Clinic

Red Deer, Alberta, Canada

LMC Clinical Research Inc. (Brampton)

Brampton, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Sameh Fikry Medicine Professional Corporation

Waterloo, Ontario, Canada

Shivinder Jolly, Nephrologist

Waterloo, Ontario, Canada

Recherche GCP Research

Montreal, Quebec, Canada

Guangdong Provincial People's Hospital

Guangzhou, , China

The First Afiliated Hospital, Sun Yet-sen University

Guangzhou, , China

Zhejiang Province People's Hospital

Hangzhou, , China

The First People's Hospital of Nanning

Nanning, , China

Huashan Hospital, Fudan University

Shanghai, , China

Shanghai Fifth People's Hospital affiliated to Fudan University

Shanghai, , China

DIKa centrum s.r.o.

Havířov, , Czechia

Synexus Czech s.r.o.

Prague, , Czechia

MILAN KVAPIL s.r.o.

Příbram, , Czechia

Hospital Slany, Internal Department

Slaný, , Czechia

Satucon Oy

Kuopio, , Finland

Tampere University Hospital

Tampere, , Finland

Turku University Hospital / TYKS

Turku, , Finland

Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen

Bad Oeynhausen, , Germany

Institut für klinische Forschung und Entwicklung (IKFE) Berlin GmbH

Berlin, , Germany

Cardiologicum Dresden und Pirna

Dresden, , Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, , Germany

DaVita Clinical Research Germany GmbH

Düsseldorf, , Germany

Synexus Clinical Research GmbH

Frankfurt, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Synexus Clinical Research GmbH

Leipzig, , Germany

Universitätsklinikum Würzburg AÖR

Würzburg, , Germany

General Hospital of Athens "Laiko"

Athens, , Greece

"Attiko" Hospital of Athens

Athens, , Greece

Univ. Gen. Hosp. of Ioannina

Ioannina, , Greece

Iatriko of Athens Group/ Iatriko of P. Faliro

P. Faliro, , Greece

Prince of Wales Hospital

Hong Kong, , Hong Kong

Queen Mary Hospital

Hong Kong, , Hong Kong

Lausmed Kft. Outpatient Unit of Internal Medicine

Baja, , Hungary

DRC Drug Research Ltd

Balatonfüred, , Hungary

Synexus Hungary Healthcare Service Ltd.

Budapest, , Hungary

Semmelweis University

Budapest, , Hungary

University Debrecen Hospital

Debrecen, , Hungary

Markhot Ferenc Hospital, Eger

Eger, , Hungary

BKS Research Ltd

Hatvan, , Hungary

Government Medical College & Hospital

Aurangabad, , India

SMS Medical College and HospitaL

Jaipur, , India

Jaipur National University Institute for Medical Science & Research Centre

Jaipur, , India

Ganesh Shankar Vidyarthi Memorial Medical College

Kanpur, , India

K R Hospital Mysore Medical College and Research Centre

Mysore, , India

Kingsway Hospitals

Nagpur, , India

All India Institute of Medical Sciences

New Delhi, , India

Shree Giriraj Multispeciality Hospital

Rajkot, , India

Galaxy Lifecare Services Pvt. Ltd.

Varanasi, , India

Christian Medical College

Vellore, , India

A.O. Policlinico Giovanni XXIII di Bari

Bari, , Italy

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

Bergamo, , Italy

Daiyukai Clinic

Aichi, Ichinomiya, , Japan

Meitetsu Hospital

Aichi, Nagoya, , Japan

Nagoya Kyoritsu Hospital

Aichi, Nagoya, , Japan

TOSAKI Clinic for Diabetes and Endocrinology

Aichi, Nagoya, , Japan

National Hospital Organization Takasaki General Medical Center

Gumma, Takasaki, , Japan

Kyoto Okamoto Memorial Hospital

Kyoto, Kuse-gun, , Japan

Ina Central Hospital

Nagano, Ina, , Japan

Suwa Red Cross Hospital

Nagano, Suwa, , Japan

Asano Clinic

Saitama, Kawagoe, , Japan

Omihachiman Community Medical Center

Shiga, Omihachiman, , Japan

The University of Tokyo Hospital

Tokyo, Bunkyo-ku, , Japan

Tokyo Medical University Hachioji Medical Center

Tokyo, Hachioji, , Japan

Miho Clinic

Tokyo, Shinagawa-ku, , Japan

Yamaura Medical Clinic

Ueda, Nagano, , Japan

Hospital Selayang

Batu Caves, , Malaysia

University Kebangsaan Malaysia

Cheras, Kuala Lumpur, , Malaysia

Klinik Kesihatan Mahmoodiah

Johor Bahru, , Malaysia

Tuanku Fauziah Hospital

Kangar, , Malaysia

Hospital Raja Perempuan Zainab II, Kota Bharu

Kota Bharu, , Malaysia

Hospital Seri Manjung

Seri Manjung, , Malaysia

Centro de Investigacion Cardiometabolica de Aguascalientes

Aguascalientes, , Mexico

Unidad de Investigación Clinica y Atencion Medica HEPA SC

Guadalajara, , Mexico

Centro Mexicano de Desarrollo de Estudios Clínicos SA -CEMDEC

México, , Mexico

Clinstile S.A. de C.V.

México, , Mexico

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

México, , Mexico

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

México, , Mexico

Hospital Universitario Dr Jose Eleuterio Gonzalez

Nuevo León, , Mexico

Akershus Universitetssykehus HF

Nordbyhagen, , Norway

Helse Stavanger, Stavanger Universitetssykehus

Stavanger, , Norway

Norzel Medical and Diagnostic Clinic

Cebu City, , Philippines

Davao Doctors Hospital

Davao City, , Philippines

West Visayas State University Medical Center

Iloilo City, , Philippines

Institute for Studies on Diabetes Foundation Inc.

Marikina City, , Philippines

The Medical City

Pasig, , Philippines

Philippine Heart Center

Quezon City, , Philippines

Senor Santo Nino Hospital

Tarlac City, , Philippines

INTERCORE Medical Center

Bydgoszcz, , Poland

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

Gdansk, , Poland

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

Katowice, , Poland

Pro Familia Altera

Katowice, , Poland

Synexus Lodz Medical Center

Lodz, , Poland

Clinical Best Solutions

Lublin, , Poland

NZOZ Specialized Ambulance "MEDICA"

Lublin, , Poland

Hospitals of Tczew S.A.

Pomorskie, , Poland

Omedica Medical Centre, Poznan

Poznan, , Poland

Synexus Poland, Branch in Poznan

Poznan, , Poland

Medical Center HCP Sp. z o.o

Poznan, , Poland

Centrum Medyczne Synexus

Warsaw, , Poland

Barwijuk Clinics

Warsaw, , 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

CHLO, EPE - Hospital de Santa Cruz

Carnaxide, , Portugal

ULS da Região de Leiria, E.P.E.

Leiria, , Portugal

APDP - Associação Protectora dos Diabéticos de Portugal

Lisbon, , Portugal

ULS de Gaia/Espinho, EPE

Vila Nova de Gaia, , Portugal

Iatros International

Bloemfontein, , South Africa

Synexus Helderberg Clinical Research Centre

Cape Town, , South Africa

TREAD Research

Cape Town, , South Africa

Langeberg Clinical Trials

Cape Town, , South Africa

Paarl Research Centre

Cape Town, , South Africa

Latiff, GHVM

Durban, , South Africa

DJW Navorsing

Krugersdorp, , South Africa

Synexus Watermeyer Clinical Research Centre

Pretoria, , South Africa

Korea University Ansan Hospital

Ansan, , South Korea

Chungbuk National University Hospital

Cheongiu, , South Korea

Inje University Ilsan Paik Hospital

Goyang, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Hospital Vall d'Hebron

Barcelona, , Spain

Hospital Público Da Mariña

Burela de Cabo, , Spain

Hospital Universitario Reina Sofía

Córdoba, , Spain

Fundación Jiménez Díaz

Madrid, , Spain

Hospital Puerta de Hierro

Majadahonda, , Spain

Centralsjukhuset, Kristianstad

Kristianstad, , Sweden

Universitetssjukhuset, Linköping

Linköping, , Sweden

Citydiabetes, Stockholm

Stockholm, , Sweden

University Hospital of Lausanne

Lausanne, , Switzerland

Istanbul University

Istanbul, , Turkey (Türkiye)

Countries

United States; Argentina; Australia; Belgium; Brazil; Bulgaria; Canada; China; Czechia; Finland; Germany; Greece; Hong Kong; Hungary; India; Italy; Japan; Malaysia; Mexico; Norway; Philippines; Poland; Portugal; South Africa; South Korea; Spain; Sweden; Switzerland; Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 38109916 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.mystudywindow.com/

Related Info

Other Identifiers

2021-001434-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1378-0005

Identifier Type: OTHER

Identifier Source: secondary_id

1378.5

Identifier Type: -

Identifier Source: org_study_id