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A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease

(RESULT)

Sponsored by Sanofi

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...

Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Feb 23, 2026

Phase

Clinical Trial

Sponsor

Sanofi

Enrollment Target

84

Start Date

Dec 2024

๐Ÿ“Š
1 of 84 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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, SAR442970, or rilzabrutinib compared with placebo in participants with primary FSGS or primary MCD aged 16 to 75 years.

Who Can Participate

Inclusion Criteria

Biopsy-proven primary FSGS or primary MCD.
UPCR โ‰ฅ3 g/g at screening.
eGFR โ‰ฅ45 mL/min/1.73 m\^2 at screening.
Documented history of UPCR reduction by โ‰ฅ40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was โ‰ฅ3.5 g/g.
โ‰ค10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
On stable dose of RAAS inhibitors for โ‰ฅ4 weeks prior to screening (if applicable); starting RAAS inhibitors treatment will not be allowed during the double-blind or OLE treatment period.
On stable dose of SGLT2 inhibitor for โ‰ฅ4 weeks prior to screening (if applicable); starting SGLT2 inhibitor treatment 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.

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

84 participants

๐ŸŽ‚

Age Range

16 Years - 75 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Sanofi

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Birmingham

Alabama

Location available
View Birmingham location page
RECRUITING

Orange

California

Location available
View Orange location page
RECRUITING

San Francisco

California

Location available
View San Francisco location page
RECRUITING

Chicago

Illinois

Location available
View Chicago location page
RECRUITING

Hinsdale

Illinois

Location available
View Hinsdale location page
RECRUITING

Ann Arbor

Michigan

Location available
View Ann Arbor location page
RECRUITING

Edina

Minnesota

Location available
View Edina location page
RECRUITING

Las Vegas

Nevada

Location available
View Las Vegas location page
RECRUITING

Albuquerque

New Mexico

Location available
View Albuquerque location page

๐Ÿ“ And 5 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

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Looking for Kidney Disease Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Kidney Disease Treatment Options in Birmingham, Alabama

If you're searching for Kidney Disease treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Orange, San Francisco and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Kidney Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 84 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Kidney Disease?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Kidney Disease

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Kidney Disease Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06500702. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.