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
Recruiting
Phase 2
Interventional Study
Focal Segmental Glomerulosclerosis
Glomerulonephritis Minimal Lesion
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 84 (estimated)
- Sponsor
- Sanofi · Industry
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About This Trial
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 ag…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Biopsy report indicative of primary FSGS or MCD, with supportive clinical presentation per Investigator's judgement.
* UPCR ≥3 g/g at screening, or ≥ 1.5 g/g in those with eGFR ≥ 60 mL/min/1.73 m2.
* eGFR ≥45 mL/min/1.73 m\^2 at screening.
* Documented history of UPCR or UACR …
Contacts
Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
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