A Study to Test BI 764198 in People With a Type of Kidney Disease Called Focal Segmental Glomerulosclerosis
- Registration Number
- NCT05213624
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This study is open to adults with a type of kidney disease called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 improves the health of the kidneys in people with FSGS. Three different doses of BI 764198 are tested in this study.
Participants are put into 4 groups randomly, which means by chance. Three of the groups receive different doses of BI 764198 and one group receives placebo. Participants are in the study for about 4 months. For about 3 months, they take BI 764198 or placebo as capsules once a day.
Placebo capsules look like BI 764198 capsules but do not contain any medicine. Participants visit the study site about 10 times. You can participate in this study from your home. In this case a research nurse will visit you for the study visits.
Kidney health is assessed based on the analysis of urine samples, which participants collect at home. At the end of the study, the results are compared between the different groups. 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
- 67
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 764198 - low dose BI 764198 BI 764198 - low dose BI 764198 - medium dose BI 764198 BI 764198 - medium dose Placebo Placebo Placebo BI 764198 - high dose BI 764198 BI 764198 - high dose
- Primary Outcome Measures
Name Time Method Number of patients achieving at least 25% reduction in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at week 12 up to 12 weeks
- Secondary Outcome Measures
Name Time Method Change in 24-hour UPCR relative to baseline at week 13 up to 13 weeks If feasible: Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 4 up to 4 weeks Change in 24-hour urinary protein excretion relative to baseline at week 12 up to 12 weeks Change in 24-hour UPCR relative to visit 3 at week 12 up to 12 weeks If feasible: Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 12 up to 12 weeks
Trial Locations
- Locations (54)
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Salford Royal
🇬🇧Salford, United Kingdom
Policlinico S. Orsola-Malpighi
🇮🇹Bologna, Italy
Nephrology Consultants, LLC
🇺🇸Huntsville, Alabama, United States
Valiance Clinical Research-South Gate-67878
🇺🇸S. Gate, California, United States
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Griffith Health
🇦🇺Southport, Queensland, Australia
Sunshine Hospital
🇦🇺AT Albans, Victoria, Australia
UZ Leuven
🇧🇪Leuven, Belgium
Fu Yang people's Hospital
🇨🇳Fuyang, China
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 Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
The First People's Hospital of Nanning
🇨🇳Nanning, China
Tongren hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, China
Shanghai Fifth People's Hospital affiliated to Fudan University
🇨🇳Shanghai, China
HOP Pellegrin
🇫🇷Bordeaux, France
HOP Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
HOP Hôtel-Dieu
🇫🇷Nantes, France
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitätsklinikum Köln (AöR)
🇩🇪Köln, Germany
A.O. Policlinico Giovanni XXIII di Bari
🇮🇹Bari, Italy
Fondazione Salvatore Maugeri
🇮🇹Pavia, Italy
New Zealand Clinical Research (ChristChurch)
🇳🇿Christchurch, New Zealand
Dunedin Hospital
🇳🇿Dunedin, New Zealand
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Fundació Puigvert
🇪🇸Barcelona, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital ClÃnic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
St Luke's Hospital
🇬🇧Bradford, United Kingdom
University of California San Francisco
🇺🇸San Francisco, California, United States
Valiance Clinical Research-Tarzana-68237
🇺🇸Tarzana, California, United States
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Elixia Fort Lauderdale, LLC
🇺🇸Fort Lauderdale, Florida, United States
South Florida Research Institute
🇺🇸Lauderdale Lakes, Florida, United States
Total Research Group, LLC
🇺🇸Miami, Florida, United States
Emory Children's Center
🇺🇸Atlanta, Georgia, United States
NANI Research, LLC
🇺🇸Oak Brook, Illinois, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Texas Tech University Health Sciences Center-Amarillo-63885
🇺🇸Amarillo, Texas, United States
Dallas Nephrology Associates Medical Clinic
🇺🇸Dallas, Texas, United States
Prolato Clinical Research Center-Houston-68087
🇺🇸Houston, Texas, United States