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Clinical Trials in India / NCT07355296
Recruiting Phase 2

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

NCT07355296 · tracked via the Priya Life Science India tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 2
Started
2026-03-23
Last updated
2026-09-16

Condition(s) studied

Proteinuric Kidney Diseases

Investigational drug(s) / intervention(s)

BI 764198Placebo matching BI 764198

BI 764198: BI 764198

Placebo matching BI 764198: Placebo matching BI 764198

Study summary

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (164)

FacilityCityRegionStatus
Nephrology Consultants, LLC Huntsville Alabama Recruiting
Kidney Disease Medical Group Glendale California Recruiting
Amicis Research Center - Balboa Granada Hills California Recruiting
Academic Medical Research Institute - Glendale Los Angeles California Recruiting
University of California Los Angeles Los Angeles California Not Yet Recruiting
Colorado Kidney Care Denver Colorado Recruiting
Florida Kidney Physicians - Boca Raton Boca Raton Florida Recruiting
Florida Kidney Physicians, LLC - Fort Lauderdale Fort Lauderdale Florida Recruiting
Total Research Group, LLC Miami Florida Recruiting
CTR Oakwater, LLC Orlando Florida Recruiting
Florida Kidney Physicians - Riverview/Brandon Riverview Florida Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois Not Yet Recruiting
Endeavor Health Evanston Illinois Not Yet Recruiting
Johns Hopkins Hospital Baltimore Maryland Not Yet Recruiting
St. Clair Nephrology Research, LLC - Shelby Township Shelby Michigan Recruiting
New York Nephrology and Dialysis Access Surgery, PC Clifton Park New York Recruiting
Queens Long Island Kidney Center Fresh Meadows New York Not Yet Recruiting
NYU Langone Nephrology Associates-Mineola Mineola New York Recruiting
Duke University Medical Center Durham North Carolina Not Yet Recruiting
Cleveland Clinic Cleveland Ohio Not Yet Recruiting
Nationwide Children's Hospital Columbus Ohio Not Yet Recruiting
Northeast Clinical Research Center Bethlehem Pennsylvania Not Yet Recruiting
Southeast Renal Research Institute Chattanooga Tennessee Recruiting
Nephrotex Research Group Dallas Texas Not Yet Recruiting
Provecta Researh Network Houston Texas Recruiting
West Virginia University Medicine Morgantown West Virginia 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 Not Yet Recruiting
Nepean Hospital Kingswood New South Wales Recruiting
John Hunter Hospital New Lambton Heights New South Wales Recruiting
Royal Brisbane and Women's Hospital Brisbane Queensland Recruiting
Princess Alexandra Hospital Woolloongabba Queensland 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

+ 124 more sites — see the full list on the official registry below.

More Boehringer Ingelheim trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07355296 on ClinicalTrials.gov ↗ ← All trials in India