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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
BI 764198
Placebo matching BI 764198
Nephrology Consultants, LLC
Huntsville, Alabama, 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
Relative change from baseline to Week 20 in 24-hr Urine protein-to-Creatinine Ratio (UPCR)
Time frame: At baseline and week 20
Treatment response, defined as at least 25% relative reduction in 24-hr UPCR from baseline to Week 20
Time frame: At baseline and week 20
Treatment response, defined as at least 40% relative reduction in 24-hr UPCR from baseline to Week 20
Time frame: At baseline and week 20
Absolute change in estimated glomerular filtration rate (eGFR) in mL/min/1.73m2 (based on cystatin C) from baseline to Week 20
Time frame: At baseline and week 20
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Florida Kidney Physicians - Boca Raton
Boca Raton, Florida, United States
CTR Oakwater, LLC
Orlando, Florida, United States
Panoramic Health
Riverview, Florida, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
...and 110 more locations