A Phase 2 interventional study of BI 764198 and Placebo matching BI 764198 in Proteinuric Kidney Diseases, sponsored by Boehringer Ingelheim. Recruiting at 164 sites in 33 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
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.
Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit
Further inclusion criteria apply.
Exclusion Criteria:
Drug: BI 764198
Drug: BI 764198
Drug: BI 764198
Drug: BI 764198
Drug: Placebo matching BI 764198
BI 764198
Also known as: Apecotrep
Placebo matching BI 764198
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
Showing the first 100 of 164 sites across 33 countries.
Plan to share: Yes — Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Supporting information: Study protocol, Sap, Csr
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Boehringer Ingelheim