A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease
- Conditions
- Diabetic Nephropathies
- Interventions
- Drug: Placebo matching BI 685509
- Registration Number
- NCT04750577
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This study is open to adults with diabetic kidney disease. The purpose of the study is to find out whether a medicine called BI 685509 improves kidney function. Three different doses of BI 685509 are tested in this study.
Participants get either one of the three doses of BI 685509 or placebo. It is decided by chance who gets which BI 685509 dose and who gets placebo. Participants take BI 685509 or placebo as tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants continue taking their usual medicine for diabetes and kidney disease throughout the study.
Participants are in the study for about 7 months. During this time, they visit the study site about 11 times. Where possible, about 6 of the 11 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.
Kidney function is assessed based on the analysis of urine samples, which participants collect at home. At the end of the trial the results are compared between the different doses of BI 685509 and placebo. During the study, the doctors also regularly check the general health of the participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 243
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo matching BI 685509 - BI 685509 1 mg TID BI 685509 - BI 685509 2 mg TID BI 685509 Low dose followed by up-titration to medium dose. BI 685509 3 mg TID BI 685509 Low dose followed by up-titration to medium dose, followed by up-titration to high-dose.
- Primary Outcome Measures
Name Time Method Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in 10-hour Urine After 20 Weeks of Trial Treatment The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2 and Week -1) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20. Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) after 20 weeks is reported. As soon as the First Morning Void sample was collected the clock starts for the 10-hour urine collection. During the 10-hour period every time the patient urinates, they collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample. Least Square Means and Standard error were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient. The Least Squares Mean (Standard error) at Week 20 is reported.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void Urine After 20 Weeks of Trial Treatment The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2 and Week -1) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20. Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in First Morning Void urine after 20 weeks of trial treatment is reported. The first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day. Least Square Means and Standard error were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient. The Least Squares Mean (Standard error) at Week 20 is reported.
Number of Patients Achieving UACR Decreases in 10-hour Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment Baseline (day -14 and -7) and week 20 (day 141). Number of patients achieving Urine Albumin Creatinine Ratio (UACR) decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment is reported. As soon as the First Morning Void sample was collected the clock starts for the 10-hour urine collection. During the 10-hour period every time the patient urinates, they collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample.
Number of Patients Achieving UACR Decreases in First Morning Void Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment Baseline (day -14 and -7) and week 20 (day 141). Number of patients achieving Albumin Creatinine Ratio (UACR) decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment. is reported. The first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day.
Trial Locations
- Locations (76)
Prince of Wales Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Tung Wah Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Universiti Sains Malaysia Hospital
🇲🇾Kelantan, Malaysia
Centenario Hospital Miguel Hidalgo
🇲🇽Aguascalientes, Mexico
SPECDERM Poznanska General Partnership
🇵🇱Bialystok, Poland
APDP - Associação Protectora dos Diabéticos de Portugal
🇵🇹Lisboa, Portugal
ULS da Região de Aveiro
🇵🇹Aveiro, Portugal
Meridian Clinical Research, LLC
🇺🇸Savannah, Georgia, United States
Macquarie University
🇦🇺Macquarie Park, New South Wales, Australia
CARe Clinic
🇨🇦Red Deer, Alberta, Canada
Centro de Investigaciones Médicas Mar del Plata
🇦🇷Mar del Plata, Argentina
Kawasaki Medical School Hospital
🇯🇵Okayama, Kurashiki, Japan
Hospital A Coruña
🇪🇸A Coruña, Spain
Fadia El Boreky Medicine Professional
🇨🇦Waterloo, Ontario, Canada
CEREHA S.A.- Centro de Estudios Renales e Hipertensión Arterial
🇦🇷Sarandi, Argentina
People's Hospital of Sichuan Province
🇨🇳Sichuan, China
Panax Clinical Research
🇺🇸Miami Lakes, Florida, United States
CEDIC - Centro de Investigacion Clinica
🇦🇷Caba, Argentina
Nepean Hospital
🇦🇺Kingswood, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Instituto Médico Especializado
🇦🇷Capital Federal, Argentina
Takai Naika Clinic
🇯🇵Kanagawa, Kamakura, Japan
Texas Institute for Kidney and Endocrine Disorders
🇺🇸Lufkin, Texas, United States
Instituto Privado de Investigaciones ClÃnica Córdoba S.A.
🇦🇷Cordoba, Argentina
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Kurume University Hospital
🇯🇵Fukuoka, Kurume, Japan
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Chubu Rosai Hospital
🇯🇵Aichi, Nagoya, Japan
Saitama Medical University Hospital
🇯🇵Saitama, Iruma-gun, Japan
University Kebangsaan Malaysia
🇲🇾Cheras, Kuala Lumpur, Malaysia
Medicome Limited Liability Company
🇵🇱Oswiecim, Poland
Daido Hospital
🇯🇵Aichi, Nagoya, Japan
P3 Research
🇳🇿Tauranga, New Zealand
The University of Tokyo Hospital
🇯🇵Tokyo, Bunkyo-ku, Japan
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
Barts and The London School of Medicine and Dentistry
🇬🇧London, United Kingdom
Hospital Selayang
🇲🇾Selangor, Malaysia
Hospital Cardiologica Aguascalientes
🇲🇽Aguascalientes, Mexico
Universitair Medisch Centrum Utrecht
🇳🇱GA Utrecht, Netherlands
Osaka General Medical Center
🇯🇵Osaka, Osaka, Japan
NBR Polska
🇵🇱Warsaw, Poland
University Hospital Coventry
🇬🇧Coventry, United Kingdom
University of Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Pratia MCM Krakow
🇵🇱Krakow, Poland
P3 Research Kapiti
🇳🇿Paraparaumu, New Zealand
Albert SchweitzerZiekenhuis
🇳🇱Dordrecht, Netherlands
DaVita Clinical Research
🇺🇸San Antonio, Texas, United States
Clinical Advancement Center, PLLC
🇺🇸San Antonio, Texas, United States
Albion Finch Medical Centre
🇨🇦Toronto, Ontario, Canada
Aarhus University Hospital
🇩🇰Aarhus N, Denmark
Steno Diabetes Center Copenhagen
🇩🇰Herlev, Denmark
Sjællands Universitetshospital
🇩🇰Roskilde, Denmark
ToCROM Clinic
🇯🇵Tokyo, Shinjyuku-ku, Japan
OCROM Clinic
🇯🇵Osaka, Suita, Japan
Instituto Médico Catamarca - IMEC
🇦🇷Rosario, Argentina
Kidney & Hypertension Center
🇺🇸Victorville, California, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Indago Research and Health Center
🇺🇸Hialeah, Florida, United States
Davita Clinical Research
🇺🇸Columbus, Georgia, United States
Research by Design, LLC
🇺🇸Chicago, Illinois, United States
Knoxville Kidney Center PLLC
🇺🇸Knoxville, Tennessee, United States
Kidney Specialists of North Houston, PLLC
🇺🇸Shenandoah, Texas, United States
Tidewater Kidney Specialists
🇺🇸Norfolk, Virginia, United States
Nakayamadera Imai Clinic
🇯🇵Hyogo, Takarazuka, Japan
Peking University Third Hospital
🇨🇳Beijing, China
Renal Research, Gosford
🇦🇺Gosford, New South Wales, Australia
Second Affiliated Hospital Chongqing Medical University
🇨🇳Chongqing, China
Queen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Tokyo-Eki Center-building Clinic
🇯🇵Tokyo, Chuo-ku, Japan
Clinstile S.A. de C.V.
🇲🇽México, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
🇲🇽Monterrey, Mexico
Hospital ClÃnico de Valencia
🇪🇸Valencia, Spain
Brookview Hills Research Associates LLC
🇺🇸Winston-Salem, North Carolina, United States
Total Renal Research
🇺🇸Bronx, New York, United States
Peking University First Hospital
🇨🇳Beijing, China