A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease (NCT06500702)
๐ฉบ Plain-English Summary (8th-Grade Level)
This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, brivekimig or rilzabrutinib compared with placebo in participants with primary FSGS or MCD aged 16 to 75 years. Study details for each participant include: The study duration will be up to 52 weeks. The treatment duration will be 24 weeks. There will be up to 16 visits.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (4 items).
Location: Investigational Site Number : 8400007 โ Birmingham, Alabama
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Genetic or secondary FSGS or MCD. Those with APOL1 risk alleles are eligible.
- Collapsing variant of FSGS.
- ESKD requiring dialysis or transplantation. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (71 Sites)
- Investigational Site Number : 8400007 โ Birmingham, Alabama
- Investigational Site Number : 8400015 โ Orange, California
- Investigational Site Number : 8400012 โ San Francisco, California
- Investigational Site Number : 8400025 โ Tampa, Florida
- Emory Children's Center- Site Number : 8400020 โ Atlanta, Georgia
- Investigational Site Number : 8400014 โ Chicago, Illinois
- Investigational Site Number : 8400017 โ Hinsdale, Illinois
- Investigational Site Number : 8400010 โ Ann Arbor, Michigan
- Investigational Site Number : 8400019 โ Edina, Minnesota
- Investigational Site Number : 8400018 โ Las Vegas, Nevada
- Investigational Site Number: 8400028 โ Albuquerque, New Mexico
- Investigational Site Number : 8400001 โ New York, New York
- Investigational Site Number : 8400021 โ Chapel Hill, North Carolina
- Investigational Site Number : 8400024 โ Dallas, Texas
- Investigational Site Number : 8400005 โ El Paso, Texas
- Investigational Site Number: 8400016 โ Houston, Texas
- Investigational Site Number : 0320001 โ Buenos Aires,
- Investigational Site Number : 0320002 โ Cรณrdoba,
- Investigational Site Number : 0360003 โ Garran, Australian Capital Territory
- Investigational Site Number : 0360001 โ Parkville, Victoria
- Investigational Site Number: 0760004 โ Botucatu, Sรฃo Paulo
- Synvia Clinical- Site Number : 0760005 โ Sรฃo Paulo, Sรฃo Paulo
- Investigational Site Number : 0760002 โ Sรฃo Paulo,
- Investigational Site Number : 0760001 โ Sรฃo Paulo,
- Investigational Site Number : 1240002 โ London, Ontario
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.