Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0274
Source ID: NCT05213624
Associated Drug: Bi 764198
Title: A Study to Test BI 764198 in People With a Type of Kidney Disease Called Focal Segmental Glomerulosclerosis
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Kidney Disease, Chronic
Interventions: DRUG: BI 764198|DRUG: Placebo
Outcome Measures: Primary: 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: Change in 24-hour UPCR relative to visit 3 at week 12, up to 12 weeks|Change in 24-hour UPCR relative to baseline at week 13, up to 13 weeks|Change in 24-hour urinary protein excretion relative to baseline at week 12, up to 12 weeks|If feasible: Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 4, up to 4 weeks|If feasible: Pre-dose plasma concentration at steady state (Cpre,ss) of BI 764198 at week 12, up to 12 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 67
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-05-03
Completion Date: 2025-01-03
Results First Posted:
Last Update Posted: 2025-04-01
Locations: Nephrology Consultants, LLC, Huntsville, Alabama, 35805, United States|Valiance Clinical Research-South Gate-67878, S. Gate, California, 90280-5219, United States|University of California San Francisco, San Francisco, California, 94121, United States|Valiance Clinical Research-Tarzana-68237, Tarzana, California, 91356, United States|The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, 90502, United States|Elixia Fort Lauderdale, LLC, Fort Lauderdale, Florida, 33308, United States|South Florida Research Institute, Lauderdale Lakes, Florida, 33313, United States|Total Research Group, LLC, Miami, Florida, 33126, United States|Emory Children's Center, Atlanta, Georgia, 30322, United States|NANI Research, LLC, Oak Brook, Illinois, 60523, United States|University of Michigan Health System, Ann Arbor, Michigan, 48109, United States|Jacobi Medical Center, Bronx, New York, 10461, United States|The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States|Duke University Medical Center, Durham, North Carolina, 27710, United States|Cleveland Clinic, Cleveland, Ohio, 44195, United States|The Ohio State University Wexner Medical Center, Columbus, Ohio, 43210, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Texas Tech University Health Sciences Center-Amarillo-63885, Amarillo, Texas, 79106, United States|Dallas Nephrology Associates Medical Clinic, Dallas, Texas, 75115, United States|Prolato Clinical Research Center-Houston-68087, Houston, Texas, 77054, United States|Liverpool Hospital, Liverpool, New South Wales, 2170, Australia|Westmead Hospital, Westmead, New South Wales, 2145, Australia|Royal Brisbane and Women's Hospital, Herston, Queensland, 4029, Australia|Griffith Health, Southport, Queensland, 4125, Australia|Sunshine Hospital, AT Albans, Victoria, 3021, Australia|UZ Leuven, Leuven, 3000, Belgium|Fu Yang people's Hospital, Fuyang, 236000, China|Guangdong Provincial People's Hospital, Guangzhou, 510080, China|The First Afiliated Hospital, Sun Yet-sen University, Guangzhou, 510080, China|Zhejiang Province People's Hospital, Hangzhou, 310014, China|The First Affiliated Hospital of Nanchang University, Nanchang, 330006, China|The First People's Hospital of Nanning, Nanning, 530000, China|Tongren hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 200051, China|Shanghai Fifth People's Hospital affiliated to Fudan University, Shanghai, 200240, China|HOP Pellegrin, Bordeaux, 33076, France|HOP Bicêtre, Le Kremlin-Bicêtre, 94270, France|HOP Hôtel-Dieu, Nantes, 44093, France|Medizinische Hochschule Hannover, Hannover, 30625, Germany|Universitätsklinikum Heidelberg, Heidelberg, 69120, Germany|Universitätsklinikum Köln (AöR), Köln, 50937, Germany|A.O. Policlinico Giovanni XXIII di Bari, Bari, 70124, Italy|Policlinico S. Orsola-Malpighi, Bologna, 40138, Italy|Fondazione Salvatore Maugeri, Pavia, 27100, Italy|New Zealand Clinical Research (ChristChurch), Christchurch, 8011, New Zealand|Dunedin Hospital, Dunedin, 9016, New Zealand|Hospital Germans Trias i Pujol, Badalona, 08916, Spain|Hospital del Mar, Barcelona, 08003, Spain|Fundació Puigvert, Barcelona, 08025, Spain|Hospital Vall d'Hebron, Barcelona, 08035, Spain|Hospital Clínic de Barcelona, Barcelona, 08036, Spain|Hospital Universitario 12 de Octubre, Madrid, 28041, Spain|St Luke's Hospital, Bradford, BD5 0NA, United Kingdom|Addenbrooke's Hospital, Cambridge, CB2 0QQ, United Kingdom|Salford Royal, Salford, M6 8HD, United Kingdom
URL: https://clinicaltrials.gov/show/NCT05213624

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress