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A study to test BI 764198 in people with a type of kidney disease called focal segmental glomerulosclerosis
EU CTIS ID: 2024-511706-23-00
What this study is testing
To explore the efficacy of BI 764198 in lowering proteinuria
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed and dated informed consent in accordance with ICH-GCP and local legislation prior to admission to the study.
- Male and female patients 18 years to 75 years (both inclusive) of age on the day of signing informed consent.
- Patients diagnosed with biopsy proven primary focal segmental glomerulosclerosis (FSGS) or documented transient receptor potential cation subfamily C member 6 (TRPC6) gene mutation causing FSGS prior to screening visit.
- Urine protein-creatinine ratio (UPCR) ≥ 1000 mg/g based on first morning void urine sample during screening.
- Patients treated with corticosteroids must be on a stable dose for at least 4 weeks prior to screening visit with no plan to change the dose until end of trial treatment.
- Patients treated with angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), finerenone, aldosterone inhibitors, or sodium-glucose cotransporter-2 (SGLT2) inhibitors should be on a stable dose for at least 4 weeks prior to screening visit with no plan to change the dose until end of trial treatment.
You likely can't join if
- Known monogenic (with the exception of TRPC6 gene mutations) or clinical or histologic evidence of secondary FSGS.
- Documented Alport syndrome, Nail Patella syndrome, diabetic nephropathy, IgA-nephropathy, lupus nephritis, or monoclonal gammopathy (e.g., multiple myeloma).
- Genito-urinary malformations with vesicoureteral reflux or renal dysplasia.
- A history of organ transplantation or planned transplantation during the course of the study.
- Uncontrolled hypertension defined as an average resting systolic blood pressure >160 mmHg calculated from the last two of the triplicate sitting blood pressure measurements at screening visit. Patients with a documented history of white coat hypertension may be included.
- Concomitant use of calcineurin inhibitors within 5 half-lives before screening visit.
See the full eligibility criteria
Who can join
- Signed and dated informed consent in accordance with ICH-GCP and local legislation prior to admission to the study.
- Male and female patients 18 years to 75 years (both inclusive) of age on the day of signing informed consent.
- Patients diagnosed with biopsy proven primary focal segmental glomerulosclerosis (FSGS) or documented transient receptor potential cation subfamily C member 6 (TRPC6) gene mutation causing FSGS prior to screening visit.
- Urine protein-creatinine ratio (UPCR) ≥ 1000 mg/g based on first morning void urine sample during screening.
- Patients treated with corticosteroids must be on a stable dose for at least 4 weeks prior to screening visit with no plan to change the dose until end of trial treatment.
- Patients treated with angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), finerenone, aldosterone inhibitors, or sodium-glucose cotransporter-2 (SGLT2) inhibitors should be on a stable dose for at least 4 weeks prior to screening visit with no plan to change the dose until end of trial treatment.
- Body Mass Index (BMI) of ≤ 40 kg/m2 at screening visit.
- Women of childbearing potential (WOCBP) must be willing and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the informed consent form (ICF).
What rules you out
- Known monogenic (with the exception of TRPC6 gene mutations) or clinical or histologic evidence of secondary FSGS.
- Documented Alport syndrome, Nail Patella syndrome, diabetic nephropathy, IgA-nephropathy, lupus nephritis, or monoclonal gammopathy (e.g., multiple myeloma).
- Genito-urinary malformations with vesicoureteral reflux or renal dysplasia.
- A history of organ transplantation or planned transplantation during the course of the study.
- Uncontrolled hypertension defined as an average resting systolic blood pressure >160 mmHg calculated from the last two of the triplicate sitting blood pressure measurements at screening visit. Patients with a documented history of white coat hypertension may be included.
- Concomitant use of calcineurin inhibitors within 5 half-lives before screening visit.
- Concomitant treatment with cytotoxic agents (cyclophosphamide, chlorambucil), or CD20 monoclonal antibody, e.g., rituximab, within 5 half-lives before screening visit.
- Treatment with metformin or dofetilide (multidrug and toxin extrusion 1 (MATE1) or organic cation transporter 2 (OCT2) substrates); dabigatran or digoxin (P-gp substrates with narrow therapeutic window) within 5 half-lives before screening visit.
- Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- China
- New Zealand
- United Kingdom
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; China; New Zealand; United Kingdom; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.