Recruiting
Phase 2

BI 764198

Sponsor:

Boehringer Ingelheim

Code:

NCT07355296

Conditions

Proteinuric Kidney Diseases

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

BI 764198

Placebo matching BI 764198

Study Details

Brief 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.

Conditions

Proteinuric Kidney Diseases

Study ID

NCT07355296

Start date

Mar 23, 2026

Status verified date

Aug, 2026

Completion date

Feb 17, 2028

Anticipated

Primary completion date

Jan 20, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Secondary focal segmental glomerulosclerosis (sFSGS) cohort

experimental: Treatment resistant primary Minimal Change Disease (TR-pMCD) cohort

experimental: Alport Syndrome cohort

experimental: Treatment resistant primary Membranous Nephropathy (TR-pMN) cohort

placebo comparator: Placebo cohort

Interventions

BI 764198

BI 764198

Placebo matching BI 764198

Placebo matching BI 764198

Primary outcome measure

  • Relative change from baseline to Week 20 in 24-hr Urine protein-to-Creatinine Ratio (UPCR) [ Time Frame: At baseline and week 20 ]

Central Contacts and Locations

Central contacts

Locations

Nephrology Consultants, LLC

Recruiting

Huntsville, Alabama, United States, 35805

Contacts

Kidney Disease Medical Group

Recruiting

Glendale, California, United States, 91206

Contacts

Amicis Research Center - Balboa

Recruiting

Granada Hills, California, United States, 91344

Contacts

Academic Medical Research Institute - Glendale

Recruiting

Los Angeles, California, United States, 90022

Contacts

Colorado Kidney Care

Recruiting

Denver, Colorado, United States, 80220

Contacts

Florida Kidney Physicians - Boca Raton

Recruiting

Boca Raton, Florida, United States, 33487

Contacts

Florida Kidney Physicians, LLC - Fort Lauderdale

Recruiting

Fort Lauderdale, Florida, United States, 33316

Contacts

Total Research Group, LLC

Recruiting

Miami, Florida, United States, 33126

Contacts

CTR Oakwater, LLC

Recruiting

Orlando, Florida, United States, 32806

Contacts

Florida Kidney Physicians - Riverview/Brandon

Recruiting

Riverview, Florida, United States, 33578

Contacts

St. Clair Nephrology Research, LLC - Shelby Township

Recruiting

Shelby, Michigan, United States, 48315

Contacts

New York Nephrology and Dialysis Access Surgery, PC

Recruiting

Clifton Park, New York, United States, 12065

Contacts

NYU Langone Nephrology Associates-Mineola

Recruiting

Mineola, New York, United States, 11501

Contacts

Southeast Renal Research Institute

Recruiting

Chattanooga, Tennessee, United States, 37404

Contacts

Provecta Researh Network

Recruiting

Houston, Texas, United States, 77027

Contacts

CaRe Clinic (Calgary)

Recruiting

Calgary, Alberta, Canada, T2N 4L7

Contacts

Victoria Hospital (LHSC)

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-09-02.