Multiple Drugs for Focal Segmental Glomerulosclerosis and Minimal Change Disease (RESULT Trial)

Phase 2

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Biopsy-proven primary FSGS or primary MCD.

* Documented history of UPCR reduction by ≥40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment emergent period, up to week 48

Summary

This trial is looking at different drugs to treat a kidney disease called primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD). The study will measure how

Who is the study for?

This trial is for people aged 16-75 with primary FSGS or MCD, proven by biopsy. Participants must be on a stable dose of certain medications like prednisone and RAAS inhibitors, weigh between 45 to 120 kg, have had a significant drop in proteinuria from past treatments, and have an eGFR (a kidney function test) of at least 45.

What is being tested?

The study compares the effects of three drugs—frexalimab, SAR442970, rilzabrutinib—and placebo on proteinuria and remission rates in nephrotic syndrome due to FSGS or MCD. It's double-blind (neither doctors nor patients know who gets which treatment), has six groups, lasts up to 76 weeks with a treatment phase of 24 weeks.

What are the potential side effects?

Potential side effects are not specified here but may include typical reactions related to immune system modulation such as infections or allergic reactions; organ-specific inflammation; changes in blood counts; fatigue; gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with FSGS or MCD through a biopsy.

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My kidney disease improved by 40% or more with specific medication.

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I have been on a stable dose of ≤10 mg/day of prednisone or its equivalent for at least 1 week.

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I have been on a stable dose of RAAS inhibitors for at least 4 weeks.

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My weight is between 45 and 120 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment emergent period, up to week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~treatment emergent period, up to week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment emergent period, up to week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Incidence of treatment-emergent adverse events, treatment-emergent serious adverse events (SAEs), treatment-emergent adverse events of special interest (AESIs) and IMP discontinuation due to TEAEs during the study

Percentage of participants achieving CR

Percentage of participants achieving FSGS partial remission endpoint