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BI 764198 for adults and adolescents with proteinuric kidney diseases

PODOMOUNT-Basket, a Phase II, Multicentre, Randomised, 2-arm Parallel-group, Double-blind, Placebo-controlled Basket Trial to Assess Safety, Tolerability, PK, and Efficacy of BI 764198 in Four Proteinuric Kidney Diseases

Phase 2 Interventional Boehringer Ingelheim · NCT07355296

This trial tests whether the oral medicine BI 764198 can help adults and adolescents who have certain proteinuric kidney diseases, including secondary FSGS, treatment‑resistant minimal change disease, Alport syndrome, or treatment‑resistant membranous nephropathy.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment132 (estimated)
Ages12 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Drugs / interventionsrituximab, obinutuzumab, cyclophosphamide
Locations148 sites (Huntsville, Alabama and 147 other locations)
Trial IDNCT07355296 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, randomized, double‑blind study that enrolls adults (and adolescents with treatment‑resistant primary MCD) with selected proteinuric kidney diseases. Participants are randomly assigned in a 2:1 ratio to receive once‑daily BI 764198 tablets or matching placebo for 20 weeks while continuing their standard-of-care medications. Key entry criteria include eGFR ≥25 mL/min/1.73 m2, BMI ≤40 kg/m2, weight ≥40 kg, and blood pressure limits at screening. Overall participation lasts about seven months including screening, treatment, and follow‑up visits.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) or adolescents (≥12 years for TR‑pMCD) with one of the listed proteinuric kidney diagnoses, an eGFR ≥25 mL/min/1.73 m2, BMI ≤40 kg/m2, weight ≥40 kg, and controlled blood pressure at screening.

Not a fit: Patients with non‑proteinuric kidney disease, eGFR below 25 mL/min/1.73 m2, or other exclusionary medical conditions are unlikely to benefit from or be eligible for this trial.

Why it matters

Potential benefit: If successful, BI 764198 could reduce proteinuria or slow kidney damage in people with these proteinuric kidney diseases.

How similar studies have performed: BI 764198 is an experimental agent and there are limited prior clinical data in these specific proteinuric kidney diseases, so comparable clinical success is currently limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Further inclusion criteria apply.

Exclusion Criteria:

* 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
* QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator's discretion) at screening visit (Visit 1) Further exclusion criteria apply.

Where this trial is running

Huntsville, Alabama and 147 other locations

+98 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Proteinuric Kidney Diseases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.