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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
67
One single capsule of 20 milligrams (mg), 40 mg, or 80 mg of BI 764198 orally, once a day.
One single capsule of placebo matching BI 764198 orally, once a day.
Nephrology Consultants, LLC
Huntsville, Alabama, United States
University of California San Francisco
San Francisco, California, United States
Valiance Clinical Research-South Gate-67878
South Gate, 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
Achievement of at Least 25% Reduction in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Baseline at Week 12
Predicted probability of patients as a percentage - predicted percentage of patients - achieving at least 25% reduction in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at Week 12 (responders) is reported. Baseline was the average of two 24-hour urine samples collected before Visit 2 (Week 0). Patients who either missed their Week 12, 24-hour UPCR assessment or their Week 12, 24-hour UPCR assessment, occurred later than 5 days after the last dose (Residual Effect Period), were considered as non-responders. The predicted probability of response was calculated using a logistic regression utilizing corticosteroid use at randomization and baseline 24-hr UPCR as covariates and is presented as a percentage.
Time frame: At baseline and Week 12.
Relative Change From Baseline at Week 12 of 24-hour Urine Protein Creatinine Ratio (UPCR)
Relative change from baseline at Week 12 in 24-hour urine protein creatinine ratio (UPCR), is reported. Baseline was the average of two 24-hour urine samples collected before Visit 2 (Week 0). An analysis of covariance (ANCOVA) model was used to estimate the relative change in UPCR from baseline to Week 12 with corticosteroid use at randomization and baseline 24-hr UPCR as covariates.
Time frame: At baseline and at Week 12.
Change in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Visit 3 at Week 12
Median change in 24-hour urine protein creatinine ratio (UPCR) relative to Visit 3 (Week 1) at Week 12, is calculated by subtracting the 24-hour UPCR, \[Week 12\] - \[Week 1\] values per patient, then by calculating the median of these changes, per treatment group.
Time frame: At Week 1 and Week 12.
Change in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Baseline at Week 13
Median change in 24-hour urine protein creatinine ratio (UPCR) relative to baseline at Week 13, is calculated by subtracting the 24-hour UPCR, \[Week 13\] - \[baseline\] values per patient,then by calculating the median of these changes, per treatment group. Baseline was the average of two, 24-hour urine samples collected before Visit 2 (Week 0).
Time frame: At baseline and at Week 13.
Change in 24-hour Urinary Protein Excretion Relative to Baseline at Week 12
Median change in 24-hour urinary excretion rate relative to baseline at Week 12, is calculated by subtracting the urinary excretion rate, \[Week 12\] - \[baseline\], values per patient, then by calculating the median of these changes, per treatment group. Baseline was the average of two, 24-hour urine samples collected before Visit 2 (Week 0).
Time frame: At baseline and at Week 12.
Pre-dose Plasma Concentration of BI 764198 at Steady-state (Cpre,ss ) at Week 4 and Week 12
Pre-dose Plasma Concentration of BI 764198 at steady-state (Cpre,ss ) at Week 4 and Week 12 is reported.
Time frame: At 671.917 hours and at 2015.917 hours after first drug administration.
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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
...and 44 more locations