PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease

Conditions

• Proteinuric Kidney Diseases

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BI 764198 — DRUG
  BI 764198
• Placebo matching BI 764198 — DRUG
  Placebo matching BI 764198

Study Details

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.

Key Dates

Start date

Mar 23, 2026

Status verified

Jun 2026

Primary completion

Jan 20, 2028

Completion

Feb 17, 2028

Study Design

Enrollment

132 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Secondary focal segmental glomerulosclerosis (sFSGS) cohort
• Experimental: Treatment resistant primary Minimal Change Disease (TR-pMCD) cohort
• Experimental: Alport Syndrome cohort
• Experimental: Treatment resistant primary Membranous Nephropathy (TR-pMN) cohort
• Placebo Comparator: Placebo cohort

Primary Outcome Measure

Relative change from baseline to Week 20 in 24-hr Urine protein-to-Creatinine Ratio (UPCR) [ Time Frame: At baseline and week 20 ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (25)

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