Adults 18 to 75, any sex, with Kidney Disease, Chronic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Achievement of at Least 25% Reduction in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Baseline at Week 12Primary· At baseline and 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 logis
Group
Value
95% CI
BI 764198 20 mg
48.9
29.2 – 68.6
BI 764198 40 mg
16.0
-1.5 – 33.5
BI 764198 80 mg
38.5
12.2 – 64.8
Placebo
11.4
-2.3 – 25.2
Relative Change From Baseline at Week 12 of 24-hour Urine Protein Creatinine Ratio (UPCR)Primary· At baseline and at Week 12.
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.
Group
Value
95% CI
BI 764198 20 mg
-38.44
-50.41 – -23.60
BI 764198 40 mg
-2.39
-24.50 – 26.19
BI 764198 80 mg
-21.52
-39.18 – 1.27
Placebo
2.28
-20.20 – 31.09
Change in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Visit 3 at Week 12Secondary· At Week 1 and 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.
Group
Value
95% CI
BI 764198 20 mg
-0.035
-0.812 – 0.669
BI 764198 40 mg
0.712
-0.169 – 0.926
BI 764198 80 mg
-0.4435
-0.837 – 0.1795
Placebo
0.106
-0.496 – 0.497
Change in 24-hour Urine Protein Creatinine Ratio (UPCR) Relative to Baseline at Week 13Secondary· At baseline and 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).
Group
Value
95% CI
BI 764198 20 mg
-0.4985
-0.8080 – 0.5050
BI 764198 40 mg
-0.151
-0.6945 – 0.7650
BI 764198 80 mg
-0.3033
-0.5875 – 0.3830
Placebo
0.0795
-0.4410 – 1.4615
Change in 24-hour Urinary Protein Excretion Relative to Baseline at Week 12Secondary· At baseline and 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).
Group
Value
95% CI
BI 764198 20 mg
-0.5036
-1.6342 – -0.1112
BI 764198 40 mg
-0.4056
-1.0535 – 0.6168
BI 764198 80 mg
-0.8967
-1.0484 – -0.0975
Placebo
0.0809
-0.8115 – 1.7913
Pre-dose Plasma Concentration of BI 764198 at Steady-state (Cpre,ss ) at Week 4 and Week 12Secondary· At 671.917 hours and at 2015.917 hours after first drug administration.
Pre-dose Plasma Concentration of BI 764198 at steady-state (Cpre,ss ) at Week 4 and Week 12 is reported.
Week 4
Group
Value
95% CI
BI 764198 20 mg
119
± 47.2
BI 764198 40 mg
266
± 64.7
BI 764198 80 mg
683
± 66.5
Week 12
Group
Value
95% CI
BI 764198 20 mg
114
± 85.9
BI 764198 40 mg
328
± 64.6
BI 764198 80 mg
509
± 45.7
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality: From first drug-administration until individual end of trial. Up to approximately 16.4 weeks. Adverse event reporting: From first drug administration until stop of treatment + residual effect period (5 days). Up to 14 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07355296 — PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease
· Phase 2
· recruiting
NCT07220083 — A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosc
· Phase 3
· recruiting
NCT07308652 — A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 764198 in the Blood
· Phase 1
· completed
NCT07368569 — A Study in Healthy People to Test Whether BI 764198 Influences the Amount of Metformin in the Body
· Phase 1
· completed
NCT04665700 — A Study in Healthy Japanese Men to Test How Well Different Doses of BI 764198 Are Tolerated
· Phase 1
· completed
Other recruiting trials for Kidney Disease, Chronic
Currently open trials in the same condition.
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· recruiting
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· NA
· recruiting
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· Phase 4
· recruiting
NCT06830473 — KTRSensor Scotland Study: An Observational Study Into Predictors and Diagnosis of Kidney Transplant Rejection
· recruiting
NCT06863194 — Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial
· Phase 1, PHASE2
· recruiting
Other Boehringer Ingelheim trials
Trials by the same sponsor.
NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection
· not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a
· not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I
· Phase 3
· not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants
· Phase 1
· not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
· Phase 3
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 12 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05213624.