BridgeMD
A study to find out if BI 764198 helps adults and adolescents with a kidney condition called focal segmental glomerulosclerosis (FSGS)
EU CTIS ID: 2025-522191-86-00
What this study is testing
The primary objective is to demonstrate superiority of BI 764198 for the mean relative change from baseline to Week 104 in 24-hour urinary protein-to-creatinine ratio (UPCR, measured in mg/g) in participants with pFSGS or those with gain-of-function mutations, some of whom are on background calcineurin inhibitor (CNI) treatment.
- Therapeutic confirmatory (Phase III)
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
- 1. Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1)
- 2. Weight of ≥40 kg at the screening visit (Visit 1)
- 3. Body Mass Index (BMI) of ≤40 kg/m2 at the screening visit (Visit 1)
- 4. Participants with a diagnosis prior to the screening visit (Visit 1) of either: - biopsy-confirmed pFSGS (based on Investigator’s judgement) OR - genetic FSGS resulting from a gain-of-function gene mutation in the TRPC6 gene (based on historical genetic test)
- 5. UPCR ≥1500 mg/g based on the mean of the spot urine sample and first morning void urine sample (both assessed by central laboratory) at the screening visit (Visit 1)
- 6. Estimated glomerular filtration rate (eGFR) - For adult participants (≥18): ≥25 mL/min/1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit (Visit 1) - For adolescent participants (12 to <18 years); ≥25 mL/min/1.73 m2 based on CKiD U25 formula using height and serum cystatin C at the screening visit (Visit 1)
You likely can't join if
- 1. Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)
- 2. Clinical or histologic evidence of secondary maladaptive or toxic forms of FSGS (based on Investigator’s judgement)
- 3. FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator’s judgement)
- 4. A history of organ transplantation or planned organ transplantation during the course of the trial
- 5. Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1)
- Further exclusion criteria apply.
See the full eligibility criteria
- 1. Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1)
- 2. Weight of ≥40 kg at the screening visit (Visit 1)
- 3. Body Mass Index (BMI) of ≤40 kg/m2 at the screening visit (Visit 1)
- 4. Participants with a diagnosis prior to the screening visit (Visit 1) of either: - biopsy-confirmed pFSGS (based on Investigator’s judgement) OR - genetic FSGS resulting from a gain-of-function gene mutation in the TRPC6 gene (based on historical genetic test)
- 5. UPCR ≥1500 mg/g based on the mean of the spot urine sample and first morning void urine sample (both assessed by central laboratory) at the screening visit (Visit 1)
- 6. Estimated glomerular filtration rate (eGFR) - For adult participants (≥18): ≥25 mL/min/1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit (Visit 1) - For adolescent participants (12 to <18 years); ≥25 mL/min/1.73 m2 based on CKiD U25 formula using height and serum cystatin C at the screening visit (Visit 1)
- Further inclusion criteria apply.
- 1. Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)
- 2. Clinical or histologic evidence of secondary maladaptive or toxic forms of FSGS (based on Investigator’s judgement)
- 3. FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator’s judgement)
- 4. A history of organ transplantation or planned organ transplantation during the course of the trial
- 5. Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1)
- Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Australia
- New Zealand
- Malaysia
- Singapore
- Brazil
- Korea, Republic of
- Taiwan
- United Kingdom
- Canada
- Argentina
- India
- Mexico
- United States
- Switzerland
- Japan
- Hong Kong
- China
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, 18-64 years, 0-17 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Australia; New Zealand; Malaysia; Singapore; Brazil and 12 more location(s). 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.