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)
Relative change from baseline to Week 20 in 24-hr Urine protein-to-Creatinine Ratio (UPCR) — At baseline and week 20
Trial sites (164)
Facility
City
Region
Status
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.
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.