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PODOMOUNT-Basket, a Phase II, Multicentre, Randomised, 2-arm Parallel-group, Double-blind, Placebo-controlled Basket Trial to Assess Safety, Tolerability, PK, and Efficacy of BI 764198 in Four Proteinuric Kidney Diseases
This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions. Participants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group. Participants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Age
12 - No limit years
Sex
ALL
Healthy Volunteers
No
Nephrology Consultants, LLC
Huntsville, Alabama, United States
Kidney Disease Medical Group
Glendale, California, United States
Amicis Research Center - Balboa
Granada Hills, California, United States
Academic Medical Research Institute - Glendale
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Colorado Kidney Center
Denver, Colorado, United States
Florida Kidney Physicians - Boca Raton
Boca Raton, Florida, United States
Florida Kidney Physicians, LLC - Fort Lauderdale
Fort Lauderdale, Florida, United States
CTR Oakwater, LLC
Orlando, Florida, United States
Panoramic Health
Riverview, Florida, United States
Start Date
March 18, 2026
Primary Completion Date
December 24, 2027
Completion Date
January 21, 2028
Last Updated
March 17, 2026
132
ESTIMATED participants
BI 764198
DRUG
Placebo matching BI 764198
DRUG
Lead Sponsor
Boehringer Ingelheim
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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