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Evaluating treatments for kidney diseases in young to middle-aged adults

A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

PHASE2 · Sanofi · NCT06500702

This study is testing three different treatments for kidney diseases in young to middle-aged adults to see if they can reduce protein levels in urine and help with symptoms over 24 weeks.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment84 (estimated)
Ages16 Years to 75 Years
SexAll
SponsorSanofi (industry)
Drugs / interventionsprednisone, frexalimab, rilzabrutinib
Locations69 sites (Birmingham, Alabama and 68 other locations)
Trial IDNCT06500702 on ClinicalTrials.gov

What this trial studies

This Phase 2a clinical trial is designed to assess the efficacy and safety of three treatments—frexalimab, SAR442970, and rilzabrutinib—compared to a placebo in participants aged 16 to 75 years with primary focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). The study will measure changes in proteinuria and the rates of remission of nephrotic syndrome over a treatment duration of 24 weeks, with a total study duration of up to 76 weeks and up to 18 visits for participants. The trial is double-blind and includes multiple arms to ensure robust data collection and analysis.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 16 to 75 years with biopsy-proven primary FSGS or MCD and specific proteinuria levels.

Not a fit: Patients with genetic or secondary forms of FSGS or MCD, or those requiring dialysis or transplantation, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new effective treatment options for patients suffering from FSGS or MCD, potentially leading to improved kidney function and quality of life.

How similar studies have performed: Other studies have explored treatments for FSGS and MCD, but the specific combination of these therapies in this trial represents a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Biopsy report indicative of primary FSGS or primary 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.
* eGFR ≥45 mL/min/1.73 m\^2 at screening.
* Documented history of UPCR (or 24-hour urine protein) reduction by \>40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g (or pre-treatment 24-hr urine protein was ≥3.5 g/day if 24-hour urine protein is used).
* ≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
* For those on a RAAS inhibitor prior to screening, the dose must be stable ≥4 weeks prior to screening; starting RAAS inhibitors or changing the dose will not be allowed during the double-blind or OLE treatment period.
* For those on an SGLT2 inhibitor prior to screening, the dose must be stable ≥4 weeks prior to screening; starting SGLT2 inhibitor treatment or changing the dose will not be allowed during the double-blind or OLE treatment periods.
* Body weight within 45 to 120 kg (inclusive) at screening.

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.

Where this trial is running

Birmingham, Alabama and 68 other locations

+19 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.