NCT07355296From ClinicalTrials.govRecruiting

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

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

Proteinuric Kidney Diseases

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Boehringer Ingelheim
Enrolment target: 132
Started: 23 March 2026
Main results due: 20 January 2028
Study sites: 164
Registry updated: 29 September 2026

Can you take part?

Aged 12 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(164)

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
University of California Los Angeles
Los Angeles, California, United States
Not yet recruiting
Colorado Kidney Care
Denver, Colorado, United States
Recruiting
Florida Kidney Physicians - Boca Raton
Boca Raton, Florida, United States
Recruiting
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
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Not yet recruiting
Endeavor Health
Evanston, Illinois, United States
Not yet 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
Queens Long Island Kidney Center
Fresh Meadows, New York, United States
Not yet recruiting
NYU Langone Nephrology Associates-Mineola
Mineola, New York, United States
Recruiting
Duke University Medical Center
Durham, North Carolina, United States
Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, United States
Not yet recruiting
Nationwide Children's Hospital
Columbus, Ohio, United States
Not yet recruiting
Northeast Clinical Research Center
Bethlehem, Pennsylvania, United States
Not yet recruiting
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
Recruiting
Nephrotex Research Group
Dallas, Texas, United States
Not yet recruiting
Provecta Researh Network
Houston, Texas, United States
Recruiting
West Virginia University Medicine
Morgantown, West Virginia, United States
Not yet 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
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Not yet 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
Hopital Erasme
Brussels, Belgium
Not yet 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 Clínicas 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
Maisonneuve-Rosemont Hospital
Monteral, Quebec, Canada
Not yet 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
Not yet recruiting

Showing 60 of 164 sites — filter to narrow it down. 106 of the 164 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07355296. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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