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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years and up |
| Sex | All |
| Enrollment | 132 (estimated) |
| Sponsor | Boehringer Ingelheim Industry-sponsored |
| Drugs / interventions | rituximab, obinutuzumab, cyclophosphamide |
| Locations | 154 sites (Huntsville, Alabama and 153 other locations) |
| Status | Recruiting |
| Started | March 23, 2026 |
| Main results expected | January 20, 2028 |
| Study ends | February 17, 2028 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07355296 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
- Study coordinator: Boehringer Ingelheim
- Email: clintriage.rdg@boehringer-ingelheim.com
- Phone: 1-800-243-0127
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.
-
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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.