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

Randomised, Double-blind, Placebo-controlled and Parallel Dose Group Trial to Investigate Efficacy and Safety of Multiple Doses of Oral BI 690517 Over 14 Weeks, Alone and in Combination With Empagliflozin, in Patients With Diabetic and Non-diabetic Chronic Kidney Disease

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.

Study Overview

• Status: Completed
• Conditions: Kidney Disease, Chronic
• Intervention / Treatment: Drug: Empagliflozin; Drug: BI 690517; Drug: Placebo to BI 690517; Drug: Placebo to empagliflozin

• Study Type: Interventional
• Enrollment (Actual): 714
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, B1824KAJ
    • CIMEL centro de Investigaciones Médicas Lanús
  • Caba, Argentina, C1060ABN
    • CEDIC - Centro de Investigacion Clinica
  • Ciudad Autonoma Buenos Aires, Argentina, C1430CKE
    • Glenny Corp. S.A. Bioclinica Argentina
  • Cordoba, Argentina, X5000AAW
    • Instituto Privado de Investigaciones Clínica Córdoba S.A.
  • Junín, Argentina, B6000GMA
    • Centro de Salud Renal Junín
  • Mar del Plata, Argentina, B7600FYK
    • Centro de Investigaciones Médicas Mar del Plata
  • Rosario, Argentina, S2000AJU
    • Instituto Médico Catamarca - IMEC
  • Villa Luro, Argentina, C1440CFD
    • CEMEDIC - Centro de Especialidades Medicas
• Australia
  • New South Wales
    • New Lambton Heights, New South Wales, Australia, 2305
      • John Hunter Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Monash University
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne
• Belgium
  • Brussel, Belgium, 1090
    • Brussels - UNIV UZ Brussel
  • Bruxelles, Belgium, 1200
    • Brussels - UNIV Saint-Luc
  • La Louvière, Belgium, 7100
    • La Louvière - UNIV CHU Tivoli
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Lodelinsart, Belgium, 6042
    • Charleroi - UNIV CHU de Charleroi
• Brazil
  • Belém, Brazil, CEP 66073-
    • Hospital Universitário João de Barros Barreto
  • Botucatu, Brazil, 18618-687
    • Faculdade de Medicina de Botucatu - UNESP
  • Curitiba, Brazil, 80440-020
    • Fundação Pró Renal Brasil
  • Porto Alegre, Brazil, 90430-001
    • Universidade Federal do Rio Grande do Sul
  • Rio de Janeiro, Brazil, 22270-060
    • Ruschel Medicina e Pesquisa Clínica
  • Sao Paulo, Brazil, 01244-030
    • Centro de Pesquisa Clinica - CPCLIN
  • Sao Paulo, Brazil, 05003090
    • BR Trials
  • São Bernardo do Campo, Brazil, 09780-000
    • CEMEC - Centro Multidisciplinar de Estudos Clínicos
  • São Paulo, Brazil, 04023-062
    • Hospital do RIM - UNIFESP
• Bulgaria
  • Ruse, Bulgaria, 7013
    • Medical Center Rusemed
  • Sofia, Bulgaria, 1784
    • Medical Center Synexus Sofia EOOD
  • Sofia, Bulgaria, 1407
    • Robert Koch Clinic Sofia
  • Stara Zagora, Bulgaria, 6000
    • MHAT Prof Stoyan Kirkovich AD
• Canada
  • Alberta
    • Red Deer, Alberta, Canada, T4N 6V7
      • The Bailey Clinic
  • Ontario
    • Brampton, Ontario, Canada, L6S 0C6
      • LMC Clinical Research Inc. (Brampton)
    • Toronto, Ontario, Canada, M5G 2N2
      • Toronto General Hospital
    • Waterloo, Ontario, Canada, N2J 1C4
      • Sameh Fikry Medicine Professional Corporation
    • Waterloo, Ontario, Canada, N2T 0C1
      • Shivinder Jolly, Nephrologist
  • Quebec
    • Montreal, Quebec, Canada, H1M 1B1
      • Recherche GCP Research
• China
  • Guangzhou, China, 510080
    • Guangdong Provincial People's Hospital
  • Guangzhou, China, 510080
    • The First Afiliated Hospital, Sun Yet-sen University
  • Hangzhou, China, 310014
    • Zhejiang Province People's Hospital
  • Nanning, China, 530000
    • The First People's Hospital of Nanning
  • Shanghai, China, 200240
    • Shanghai Fifth People's Hospital affiliated to Fudan University
  • Shanghai, China, 200040
    • Huashan Hospital, Fudan University
• Czechia
  • Havirov, Czechia, 73601
    • DIKa centrum s.r.o.
  • Prague, Czechia, 120 00
    • Synexus Czech s.r.o.
  • Pribram, Czechia, 26101
    • MILAN KVAPIL s.r.o.
  • Slany, Czechia, 274 01
    • Hospital Slany, Internal Department
• Finland
  • Kuopio, Finland, 70100
    • Satucon oy
  • Tampere, Finland, 33521
    • Tampere university Hospital
  • Turku, Finland, 20520
    • Turku University Hospital / TYKS
• Germany
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen
  • Berlin, Germany, 10437
    • Institut für klinische Forschung und Entwicklung (IKFE) Berlin GmbH
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus Dresden
  • Dresden, Germany, 01277
    • Cardiologicum Dresden und Pirna
  • Düsseldorf, Germany, 40210
    • DaVita Clinical Research Germany GmbH
  • Frankfurt, Germany, 60313
    • Synexus Clinical Research GmbH
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Leipzig, Germany, 04103
    • Synexus Clinical Research GmbH
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg AÖR
• Greece
  • Athens, Greece, 115 27
    • General Hospital of Athens "Laiko"
  • Athens, Greece, 124 62
    • "Attiko" Hospital of Athens
  • Ioannina, Greece, 455 00
    • Univ. Gen. Hosp. of Ioannina
  • P. Faliro, Greece, 17562
    • Iatriko of Athens Group/ Iatriko of P. Faliro
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong, 999077
    • Prince of Wales Hospital
• Hungary
  • Baja, Hungary, 6500
    • Lausmed Kft. Outpatient Unit of Internal Medicine
  • Balatonfured, Hungary, 8230
    • DRC Drug Research Ltd
  • Budapest, Hungary, 1083
    • Semmelweis University
  • Budapest, Hungary, 1036
    • Synexus Hungary Healthcare Service Ltd.
  • Debrecen, Hungary, 4032
    • University Debrecen Hospital
  • Eger, Hungary, 3300
    • Markhot Ferenc Hospital, Eger
  • Hatvan, Hungary, 3000
    • BKS Research Ltd
• India
  • Aurangabad, India, 431001
    • Government Medical College & Hospital
  • Jaipur, India, 302001
    • SMS Medical College and Hospital
  • Jaipur, India, 302017
    • Jaipur National University Institute for Medical Science & Research Centre
  • Kanpur, India, 208002
    • Ganesh Shankar Vidyarthi Memorial Medical College
  • Mysore, India, 570001
    • K R Hospital Mysore Medical College and Research Centre
  • Nagpur, India, 440001
    • Kingsway Hospitals
  • New Delhi, India, 110029
    • All India Institute of Medical Sciences
  • Rajkot, India, 360005
    • Shree Giriraj Multispeciality Hospital
  • Varanasi, India, 221010
    • Galaxy Lifecare Services Pvt. Ltd.
  • Vellore, India, 632004
    • Christian Medical College
• Italy
  • Bari, Italy, 70124
    • A.O. Policlinico Giovanni XXIII di Bari
  • Bergamo, Italy, 24127
    • ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII
• Japan
  • Aichi, Ichinomiya, Japan, 491-8551
    • Daiyukai Clinic
  • Aichi, Nagoya, Japan, 451-8511
    • Meitetsu Hospital
  • Aichi, Nagoya, Japan, 454-0933
    • Nagoya Kyoritsu Hospital
  • Aichi, Nagoya, Japan, 468-0009
    • Tosaki Clinic for Diabetes and Endocrinology
  • Gumma, Takasaki, Japan, 370-0829
    • National Hospital Organization Takasaki General Medical Center
  • Kyoto, Kuse-gun, Japan, 613-0034
    • Kyoto Okamoto Memorial Hospital
  • Nagano, Ina, Japan, 396-8555
    • Ina Central Hospital
  • Nagano, Suwa, Japan, 392-8510
    • Suwa Red Cross Hospital
  • Saitama, Kawagoe, Japan, 350-0851
    • Asano Clinic
  • Shiga, Omihachiman, Japan, 523-0082
    • Omihachiman Community Medical Center
  • Tokyo, Bunkyo-ku, Japan, 113-8655
    • The University of Tokyo Hospital
  • Tokyo, Hachioji, Japan, 193-0998
    • Tokyo Medical University Hachioji Medical Center
  • Tokyo, Shinagawa-ku, Japan, 141-0032
    • Miho Clinic
  • Ueda, Nagano, Japan, 386-0407
    • Yamaura Medical Clinic
• Korea, Republic of
  • Ansan, Korea, Republic of, 15355
    • Korea University Ansan Hospital
  • Cheongiu, Korea, Republic of, 28644
    • Chungbuk National University Hospital
  • Goyang, Korea, Republic of, 10380
    • Inje University Ilsan Paik Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 156-707
    • SMG-SNU Boramae Medical Center
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital
• Malaysia
  • Batu Caves, Malaysia, 68100
    • Hospital Selayang
  • Cheras, Kuala Lumpur, Malaysia, 56000
    • University Kebangsaan Malaysia
  • Johor Bahru, Malaysia, 80100
    • Klinik Kesihatan Mahmoodiah
  • Kangar, Malaysia, 01000
    • Tuanku Fauziah Hospital
  • Kota Bharu, Malaysia, 15200
    • Hospital Raja Perempuan Zainab II, Kota Bharu
  • Seri Manjung, Malaysia, 32040
    • Hospital Seri Manjung
• Mexico
  • Aguascalientes, Mexico, 20230
    • Centro de Investigación Cardiometabólica de Aguascalientes
  • Guadalajara, Mexico, 44670
    • Unidad de Investigación Clinica y Atencion Medica HEPA SC
  • Mexico, Mexico, 06100
    • Centro Mexicano de Desarrollo de Estudios Clínicos SA -CEMDEC
  • Mexico, Mexico, 20010
    • Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V.
  • México, Mexico, 06700
    • Clinstile S.A. de C.V.
  • México, Mexico, 11650
    • CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc
  • Nuevo León, Mexico, 64460
    • Hospital Universitario Dr Jose Eleuterio Gonzalez
• Norway
  • Nordbyhagen, Norway, 1478
    • Akershus universitetssykehus HF
  • Stavanger, Norway, 4011
    • Helse Stavanger, Stavanger Universitetssykehus
• Philippines
  • Cebu City, Philippines, 6000
    • Norzel Medical and Diagnostic Clinic
  • Davao City, Philippines, 8000
    • Davao Doctors Hospital
  • Iloilo City, Philippines, 5000
    • West Visayas State University Medical Center
  • Marikina city, Philippines, 1810
    • Institute for Studies on Diabetes Foundation Inc.
  • Pasig City, Philippines, 1605
    • The Medical City
  • Quezon City, Philippines, 850
    • Philippine Heart Center
  • Tarlac, Philippines, 2306
    • Senor Santo Nino Hospital
• Poland
  • Bydgoszcz, Poland, 85-605
    • INTERCORE Medical Center
  • Gdansk, Poland, 80-382
    • Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk
  • Katowice, Poland, 40-040
    • Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice
  • Katowice, Poland, 40-648
    • Pro Familia Altera
  • Lodz, Poland, 90127
    • Synexus Lodz Medical Center
  • Lublin, Poland, 20-538
    • NZOZ Specialized Ambulance "MEDICA"
  • Lublin, Poland, 20-078
    • Clinical Best Solutions
  • Pomorskie, Poland, 83-110
    • Hospitals of Tczew S.A.
  • Poznan, Poland, 60-111
    • Omedica Medical Centre, Poznan
  • Poznan, Poland, 61-485
    • Independent Health Care Center HCP Medical Center
  • Poznan, Poland, 60-702
    • Synexus Poland, Branch in Poznan
  • Warszawa, Poland, 02-884
    • Barwijuk Clinics
  • Warszawa, Poland, 02-672
    • Centrum Medyczne SYNEXUS
  • Wroclaw, Poland, 50-088
    • Synexus Poland, Branch in Wroclaw
• Portugal
  • Almada, Portugal, 2801-951
    • Hospital Garcia de Orta, EPE
  • Aveiro, Portugal, 3810-164
    • Centro Hospitalar do Baixo Vouga - Hospital Infante Dom Pedro
  • Carnaxide, Portugal, 2790-134
    • CHLO, EPE - Hospital de Santa Cruz
  • Leiria, Portugal, 2410-197
    • Centro Hosp. de Leiria-Pombal
  • Lisboa, Portugal, 1250-189
    • APDP - Associação Protectora dos Diabéticos de Portugal
  • Vila Nova de Gaia, Portugal, 4434-502
    • Centro Hospitalar de Vila Nova de Gaia
• South Africa
  • Bloemfontein, South Africa, 9324
    • Iatros International
  • Cape Town, South Africa, 7130
    • Synexus Helderberg Clinical Research Centre
  • Cape Town, South Africa, 7500
    • TREAD Research
  • Cape Town, South Africa, 7570
    • Langeberg Clinical Trials
  • Cape Town, South Africa, 7646
    • Paarl Research Centre
  • Durban, South Africa, 4001
    • Latiff, GHVM
  • Krugersdorp, South Africa, 1739
    • DJW Navorsing
  • Pretoria, South Africa, 0184
    • Synexus Watermeyer Clinical Research Centre
• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Burela, Spain, 27880
    • Hospital Público Da Mariña
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz
  • Majadahonda, Spain, 28222
    • Hospital Puerta de Hierro
• Sweden
  • Kristianstad, Sweden, 291 33
    • Centralsjukhuset, Kristianstad
  • Linköping, Sweden, 581 85
    • Universitetssjukhuset, Linköping
  • Stockholm, Sweden, 112 21
    • Citydiabetes, Stockholm
• Switzerland
  • Lausanne, Switzerland, 1011
    • University Hospital of Lausanne
• Turkey
  • Istanbul, Turkey, 34093
    • Istanbul University
• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Aventiv Research Inc.
    • Phoenix, Arizona, United States, 85027
      • AKDHC Medical Research Services, LLC
  • California
    • Canyon Country, California, United States, 91351
      • Clearview Medical Research, LLC
    • Long Beach, California, United States, 90806
      • Pacific Renal Associates
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
    • Northridge, California, United States, 91324
      • Amicis Research Center
    • San Dimas, California, United States, 91773
      • California Kidney Specialists
  • Colorado
    • Denver, Colorado, United States, 80230
      • Colorado Kidney Care
  • Florida
    • Brandon, Florida, United States, 33511
      • Clinical Research of Brandon LLC
    • Coral Gables, Florida, United States, 33134
      • Horizon Research Group
    • Fort Lauderdale, Florida, United States, 33308
      • Elixia Fort Lauderdale, LLC
    • Lauderdale Lakes, Florida, United States, 33313
      • South Florida Research Institute
    • Miami, Florida, United States, 33126
      • Total Research Group, LLC
    • Miami, Florida, United States, 33014
      • San Marcus Research Clinic, Inc.
    • Miami, Florida, United States, 33150
      • Horizon Research Group, LLC
    • Ocoee, Florida, United States, 34761
      • West Orange Endocrinology
    • Pembroke Pines, Florida, United States, 33024
      • Pines Care Research Center
    • Temple Terrace, Florida, United States, 33637
      • Elixia Tampa, LLC
  • Idaho
    • Nampa, Idaho, United States, 83687
      • Boise Kidney and Hypertension PLLC
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Cedar Crosse Research Center
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Kansas Nephrology Research Institute, LLC
  • Michigan
    • Flint, Michigan, United States, 48504
      • Aa Mrc Llc
    • Flint, Michigan, United States, 48532
      • Elite Research Center, LLC
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Clinical Research Consultants, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89103
      • Forte Family Practice
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • New Mexico Clinical Research and Osteoporosis Center, Inc.
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • Triad Internal Medicine
    • Morehead City, North Carolina, United States, 28557
      • Lucas Research, Inc.
  • Ohio
    • Canton, Ohio, United States, 44718
      • Diabetes & Endocrinology Associates of Stark County
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Heritage Valley Medical Group
    • Upland, Pennsylvania, United States, 19013
      • Elixia Upland, LLC
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Monument Health
  • Tennessee
    • Knoxville, Tennessee, United States, 37923
      • Knoxville Kidney Center PLLC
  • Texas
    • Dallas, Texas, United States, 75231
      • Research Institute of Dallas
    • El Paso, Texas, United States, 79935
      • Academy Of Diabetes, Thyroid And Endocrine, PA
    • Houston, Texas, United States, 77024
      • PrimeCare Medical Group
    • Lufkin, Texas, United States, 75904
      • P&I Clinical Research, LLC
    • Sugar Land, Texas, United States, 77478
      • Simcare Medical Research, LLC
  • Washington
    • Spokane, Washington, United States, 99204
      • Providence Medical Research Center
    • Tacoma, Washington, United States, 98405
      • Universal Research Group, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

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

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

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

Exclusion criteria

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

Further criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment period: Empagliflozin + BI 690517	Drug: Empagliflozin; Empagliflozin; Drug: BI 690517; BI 690517
Experimental: Treatment period: Empagliflozin + Placebo to BI 690517	Drug: Empagliflozin; Empagliflozin; Drug: Placebo to BI 690517; Placebo to BI 690517
Experimental: Treatment period: Placebo to Empagliflozin + BI 690517	Drug: BI 690517; BI 690517
Placebo Comparator: Treatment period: Placebo to Empagliflozin + Placebo to BI 690517	Drug: Placebo to BI 690517; Placebo to BI 690517; Drug: Placebo to empagliflozin; Placebo to empagliflozin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from treatment period baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in First Morning Void urine	up to 14 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
UACR response I, defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline	up to 14 weeks
UACR response II, defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline	up to 14 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Actual): June 19, 2023
• Study Completion (Actual): July 10, 2023

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin
• Other Study ID Numbers: 1378.5; 2021-001434-19 (EudraCT Number); 1378-0005 (Other Identifier: Boehringer Ingelheim)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Once the time frame criteria given under number 4 are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

• IPD Sharing Time Frame: After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No