BridgeMD
New treatment option for Focal Segmental Glomerulosclerosis
Official title A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
ClinicalTrials.gov ID: NCT07220083
What this study is testing
What is BI 764198?
BI 764198 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for focal segmental glomerulosclerosis.
Also referred to as Apecotrep.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- PODOMOUNT-pFSGS This study is open to adults and adolescents with a kidney condition called focal segmental glomerulosclerosis (FSGS). The purpose of this study is to find out whether a medicine called BI 764198 helps people with FSGS.
- Phase 3: a large, late-stage study
- Time commitment: about 2 years
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1)
- Weight of ≥40 kg at the screening visit (Visit 1)
- Body mass index (BMI) of ≤40 kg/m² at the screening visit (Visit 1)
- Participants with a diagnosis prior to the screening visit (Visit 1) of either:
- Biopsy-confirmed primary focal segmental glomerulosclerosis (pFSGS) (based on Investigator's judgement) OR
You likely can't join if
- Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)
- Clinical or histologic evidence of secondary adaptive or toxic forms of FSGS (based on Investigator's judgement)
- FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement)
- A history of organ transplantation or planned organ transplantation during the course of the trial
- Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the last 6 months prior to screening (Visit 1)...
See the full eligibility criteria
- Male or female participants ≥12 years old on the day of signing informed consent/assent (Visit 1)
- Weight of ≥40 kg at the screening visit (Visit 1)
- Body mass index (BMI) of ≤40 kg/m² at the screening visit (Visit 1)
- Participants with a diagnosis prior to the screening visit (Visit 1) of either:
- Biopsy-confirmed primary focal segmental glomerulosclerosis (pFSGS) (based on Investigator's judgement) OR
- Genetic focal segmental glomerulosclerosis (FSGS) resulting from a gain-of-function mutation in the transient receptor potential cation subfamily C member 6 (TRPC6) gene (based on historical genetic test)
- Urine protein-creatinine ratio (UPCR) ≥1500 mg/g based on the mean of the spot urine sample and first morning void (FMV) urine sample (both assessed by central laboratory) at the screening visit (Visit 1)
- Estimated glomerular filtration rate (eGFR)
- For adult participants (≥18 years): ≥25 mL/min/1.73 m² (chronic kidney disease epidemiology collaboration (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 chronic kidney disease under 25 years (CKiD U25) formula using serum cystatin C at the screening visit (Visit 1) Further apply.
- Known monogenic or syndromic causes of FSGS (with the exception of TRPC6 gain-of-function gene mutations)
- Clinical or histologic evidence of secondary adaptive or toxic forms of FSGS (based on Investigator's judgement)
- FSGS of undetermined cause (FSGS-UC) with a diagnosis prior to the screening visit (Visit 1) (based on Investigator's judgement)
- A history of organ transplantation or planned organ transplantation during the course of the trial
- 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
- Alabaster, Alabama, United States
- Huntsville, Alabama, United States
- Surprise, Arizona, United States
- Fremont, California, United States
- Glendale, California, United States
- Granada Hills, California, United States
- Huntington Park, California, United States
- Los Angeles, California, United States
- Redding, California, United States
- San Dimas, California, United States
- San Francisco, California, United States
- Tarzana, California, United States
- Victorville, California, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Boca Raton, Florida, United States
- Fort Lauderdale, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Riverview, Florida, United States
+ 226 more site(s).
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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alabaster, Alabama, United States; Huntsville, Alabama, United States; Surprise, Arizona, United States; Fremont, California, United States; Glendale, California, United States; Granada Hills, California, United States and 240 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 ClinicalTrials.gov; the study team decides eligibility.