Imagine living with a kidney disease that makes you feel constantly unwell and limits your daily life. For many, primary focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) can feel like an uphill battle, as current treatments don’t work for everyone. This study is exploring three new drugs—frexalimab, brivekimig, and rilzabrutinib—to see if they can effectively reduce protein in urine, a key indicator of kidney health. Over 76 weeks, participants will receive one of these treatments or a placebo, with the hope of finding a better way to manage their symptoms. If these drugs prove effective, they could lead to fewer people experiencing the debilitating effects of nephrotic syndrome, which is often tied to these kidney diseases. However, it's important to remember that these treatments are still in the testing phase, and we need to wait for the results to understand their true impact. The journey to better kidney health continues, and this research offers a glimmer of hope for those affected.
Could New Treatments Help Those Struggling with Kidney Disease?
Plain Language Summary
What this means for you:
New treatments for kidney disease could lead to better management and improved lives for patients. What this means for you:
New treatments for kidney disease could lead to better management and improved lives for patients. View Original Abstract ↓
Status: RECRUITING | Phase: PHASE2
Condition(s): Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
Intervention(s): frexalimab (DRUG), brivekimig (DRUG), rilzabrutinib (DRUG), placebo (DRUG)
This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or primary 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 primary MCD aged 16 to 75 years.
Study details for each participant include:
The study duration will be up to 76 weeks. The treatment duration will be 24 weeks. There will be up to 18 visits.
Primary Outcome(s): Percent reduction in urine protein to creatinine ratio (UPCR)
Enrollment: 84 (ESTIMATED)
Lead Sponsor: Sanofi
Start: 2024-12-19 | Primary Completion: 2026-12-23