A Study to Test BI 764198 for Kidney Disease
This study is testing a medicine called BI 764198 to see if it helps adults and adolescents with certain types of kidney disease. These conditions include 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 TR-pMCD can also join. You would be randomly assigned to one of two groups: one takes BI 764198 tablets, and the other takes placebo tablets (which look the same but have no medicine). You would take one tablet daily for 20 weeks. The study will measure changes in your urine protein-to-creatinine ratio (UPCR) to see if the medicine is effective. The study aims to enroll 132 participants, but its current status is unclear.
- Study design
- This is an interventional study where participants are randomly assigned to receive either BI 764198 or a placebo. The study plans to enroll 132 participants.
- What's involved
- You would take a tablet once a day for 20 weeks. Your 24-hour urine protein-to-creatinine ratio (UPCR) will be measured at the beginning and at week 20.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at Week 20, which is the duration of treatment.
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NCT07355296
PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease
Recruiting
PHASE2Ages 12+InterventionalTreatmentBoehringer Ingelheim
~132 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:BI 764198Placebo matching BI 764198
At a glance
Recruiting sites
89 of 163 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relative change from baseline to Week 20 in 24-hr Urine protein-to-Creatinine Ratio (UPCR)
Measured over At baseline and week 20
Conditions
Where it's being run
163 sites across 49 statesChina12
India9
Italy8
Germany6
Japan6
Mexico6
Turkey (Türkiye)6
Florida5
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent/assent (Visit 1)
Body Mass Index (BMI) of ≤40 kg/m2 at screening visit (Visit 1)
Weight of ≥40 kg at screening
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
For adult participants (≥18); ≥25 mL/min/1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit
For adolescent participants (\<18); ≥25 mL/min/1.73 m2 (chronic kidey disease under 25 years (CKiD U25) formula using height and serum cystatin C) at the screening visit
Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants \<18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and "true" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants \<18)
Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not tolerated or indicated as per the discretion of the investigator
If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a stable dose for at least 8 weeks prior to the screening visit (Visit 1), preferably with no plan to change the dose until the end of the randomised double-blind treatment period (i.e. EoT, Week 20)
Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil/-sodium, cyclophosphamide) must be on a stable dose for at least 12 weeks prior to the screening visit (Visit 1) with no plans to change their dose during the trial treatment period
Patients treated/to be treated with oral glucocorticoids have to be at a dose ≤10 mg/d prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period.
Exclusion
A history of organ transplantation or planned transplantation during the course of the study
Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)
Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial
Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit
Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (CYP3A4/5) within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2)
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \>3X the upper limit of normal (ULN) at screening visit (Visit 1)
Clinically significant laboratory abnormalities or medical conditions which pose a safety risk for the participant or may interfere with the trial objectives in the investigator's opinion (except for renal function tests or deviation of clinical laboratory values that are related to the podocytopathy in question) at screening visit
What this trial measures
- Relative change from baseline to Week 20 in 24-hr Urine protein-to-Creatinine Ratio (UPCR)At baseline and week 20