Clinical trial Recruiting at 115 sites Phase 2 Interventional Ages 12 and up

BI 764198 for adults and adolescents with proteinuric kidney diseases

Official title: 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

Run by Boehringer Ingelheim · NCT07355296 · Data updated 2026-11-12

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
Ages12 Years and up
SexAll
Enrollment132 (estimated)
SponsorBoehringer Ingelheim
Industry-sponsored
Drugs / interventionsrituximab, obinutuzumab, cyclophosphamide
Locations154 sites (Huntsville, Alabama and 153 other locations)
StatusRecruiting
StartedMarch 23, 2026
Main results expectedJanuary 20, 2028
Study endsFebruary 17, 2028
Registry record updatedOctober 28, 2026
Trial IDNCT07355296 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Nephrology Consultants, LLC
    Huntsville, Alabama, United States
    Recruiting
  • Kidney Disease Medical Group
    Glendale, California, United States
    Recruiting
  • Amicis Research Center - Balboa
    Granada Hills, California, United States
    Recruiting
  • Academic Medical Research Institute - Glendale
    Los Angeles, California, United States
    Recruiting
  • Colorado Kidney Care
    Denver, Colorado, United States
    Recruiting
  • Florida Kidney Physicians - Boca Raton
    Boca Raton, Florida, United States
    Recruiting
Show 44 more locations
  • Florida Kidney Physicians, LLC - Fort Lauderdale
    Fort Lauderdale, Florida, United States
    Recruiting
  • Total Research Group, LLC
    Miami, Florida, United States
    Recruiting
  • CTR Oakwater, LLC
    Orlando, Florida, United States
    Recruiting
  • Florida Kidney Physicians - Riverview/Brandon
    Riverview, Florida, United States
    Recruiting
  • Endeavor Health
    Evanston, Illinois, United States
    Recruiting
  • Johns Hopkins Hospital
    Baltimore, Maryland, United States
    Recruiting
  • St. Clair Nephrology Research, LLC - Shelby Township
    Shelby, Michigan, United States
    Recruiting
  • New York Nephrology and Dialysis Access Surgery, PC
    Clifton Park, New York, United States
    Recruiting
  • NYU Langone Nephrology Associates-Mineola
    Mineola, New York, United States
    Recruiting
  • Southeast Renal Research Institute
    Chattanooga, Tennessee, United States
    Recruiting
  • Provecta Researh Network
    Houston, Texas, United States
    Recruiting
  • Terapia Renal Domiciliaria
    Buenos Aires, Argentina
    Recruiting
  • Centro Medico Dra Laura Maffei
    Ciudad Autonoma Buenos Aires, Argentina
    Recruiting
  • Clinica Privada Velez Sarfield
    Córdoba, Argentina
    Recruiting
  • CardioAlem Investigaciones
    San Isidro, Argentina
    Recruiting
  • Nepean Hospital
    Kingswood, New South Wales, Australia
    Recruiting
  • John Hunter Hospital
    New Lambton Heights, New South Wales, Australia
    Recruiting
  • Royal Brisbane and Women's Hospital
    Brisbane, Queensland, Australia
    Recruiting
  • Princess Alexandra Hospital
    Woolloongabba, Queensland, Australia
    Recruiting
  • AZORG Ziekenhuis
    Aalst, Belgium
    Recruiting
  • Az Maria Middelares Gent
    Ghent, Belgium
    Recruiting
  • UZ Leuven
    Leuven, Belgium
    Recruiting
  • Universidade Federal do Ceara
    Fortaleza, Brazil
    Recruiting
  • Hospital de Clinicas de Porto Alegre
    Porto Alegre, Brazil
    Recruiting
  • Fundacao Oswaldo Ramos (Hospital do Rim)
    São Paulo, Brazil
    Recruiting
  • Hospital das Clinicas da Faculdade de Medicina da USP
    São Paulo, Brazil
    Recruiting
  • Instituto da Crianca e do Adolescente
    São Paulo, Brazil
    Recruiting
  • CaRe Clinic (Calgary)
    Calgary, Alberta, Canada
    Recruiting
  • Victoria Hospital (LHSC)
    London, Ontario, Canada
    Recruiting
  • Peking University First Hospital
    Beijing, China
    Recruiting
  • Beijing Tsinghua Changgung Hospital
    Beijing, China
    Recruiting
  • West China Hospital, Sichuan University
    Chengdu, China
    Recruiting
  • Guangdong Provincial People's Hospital
    Guangzhou, China
    Recruiting
  • The First Affiliated Hospital of Nanchang University
    Nanchang, China
    Recruiting
  • Zhongda Hospital Southeast University
    Nanjing, China
    Recruiting
  • The First People's Hospital of Nanning
    Nanning, China
    Recruiting
  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
    Shanghai, China
    Recruiting
  • Shanghai General Hospital
    Shanghai, China
    Recruiting
  • Sichuan Provincial People's Hospital
    Sichuan, China
    Recruiting
  • Renmin Hospital of Wuhan University
    Wuhan, China
    Recruiting
  • Zhongshan Hospital Affiliated to Xiamen University
    Xiamen, China
    Recruiting
  • Specijalna Bolnica Medico
    Rijeka, Croatia
    Recruiting
  • General Hospital Vinkovci
    Vinkovci, Croatia
    Recruiting
  • Clinical Hospital Sveti Duh
    Zagreb, Croatia
    Recruiting

+104 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Sparsentan for high-grade proteinuria linked to VEGF inhibitors

    This pilot study tests whether sparsentan can reduce severe proteinuria in adults with cancer who are being treated with VEGF signaling pathway inhibitors.

    Recruiting Phase 1 Brigham and Women's Hospital · Boston, Massachusetts · NCT07224776

  • Evaluating MZE829 for Kidney Disease Related to APOL1 Genotype

    This study is testing a new treatment called MZE829 to see if it can help adults with kidney disease related to a specific genetic marker and reduce protein in their urine.

    Recruiting at 79 sites Phase 2 Maze Therapeutics · Decatur, Alabama and 78 other locations · NCT06830629

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.