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New hope for rare kidney diseases: three drugs enter trial

NCT ID NCT06500702

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This study tests three experimental drugs—frexalimab, brivekimig, and rilzabrutinib—in people aged 16 to 75 with two rare kidney diseases: FSGS and MCD. The goal is to see if these drugs can reduce protein in the urine, a key sign of kidney damage, and help patients achieve remission. The trial is double-blind and placebo-controlled, meaning some participants will receive a dummy treatment for comparison. It involves 84 participants across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
frexalimab, brivekimig, and rilzabrutinib (drugs that target the immune system)
What this could lead to
If successful, these drugs could offer new treatment options for people with FSGS or MCD, potentially reducing protein in the urine and helping achieve remission.
What could go wrong
This is an early Phase 2a study with only 84 participants, so results may not apply to everyone. The drugs may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (or 24-hour urine protein or 24-hour urine albumin) reduction by \>40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g or equivalent for UACR (or pre-treatment 24-hr urine protein was ≥3.5 g/day if 24-hour urine protein is used or equivalent for 24-hr urine albumin if 24-hour urine albumin 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.

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Conditions

The condition(s) this trial relates to.

focal segmental glomerulosclerosis lipoid nephrosis primary focal segmental glomerulosclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Focal segmental glomerulosclerosis Glomerulonephritis minimal lesion

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    71 sites in 22 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Emory Children's Center- Site Number : 8400020

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Investigational Site Number : 0320001

    RECRUITING

    Buenos Aires, 1431, Argentina

  • Investigational Site Number : 0320002

    RECRUITING

    Córdoba, 5016, Argentina

  • Investigational Site Number : 0360001

    RECRUITING

    Parkville, Victoria, 3050, Australia

  • Investigational Site Number : 0360003

    RECRUITING

    Garran, Australian Capital Territory, 2605, Australia

  • Investigational Site Number : 0760001

    RECRUITING

    São Paulo, 05403-000, Brazil

  • Investigational Site Number : 0760002

    RECRUITING

    São Paulo, 04038-002, Brazil

  • Investigational Site Number : 1240001

    RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

  • Investigational Site Number : 1240002

    RECRUITING

    London, Ontario, N6A 5A5, Canada

  • Investigational Site Number : 1240005

    RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • Investigational Site Number : 1240006

    RECRUITING

    Québec, Quebec, G1R 2J6, Canada

  • Investigational Site Number : 1520002

    RECRUITING

    Santiago, Reg Metropolitana de Santiago, 8330034, Chile

  • Investigational Site Number : 1520003

    RECRUITING

    Temuco, La Araucanía, 4781151, Chile

  • Investigational Site Number : 1560001

    RECRUITING

    Beijing, 100034, China

  • Investigational Site Number : 1560003

    RECRUITING

    Chengdu, 610072, China

  • Investigational Site Number : 1560004

    RECRUITING

    Shanghai, 200080, China

  • Investigational Site Number : 1580001

    RECRUITING

    Taichung, 404, Taiwan

  • Investigational Site Number : 1580002

    RECRUITING

    Taipei, 100, Taiwan

  • Investigational Site Number : 2030001

    RECRUITING

    Prague, 128 08, Czechia

  • Investigational Site Number : 2030002

    RECRUITING

    Olomouc, 779 00, Czechia

  • Investigational Site Number : 2500001

    RECRUITING

    Paris, 75015, France

  • Investigational Site Number : 2500002

    RECRUITING

    Créteil, 94010, France

  • Investigational Site Number : 2760002

    RECRUITING

    Berlin, 10117, Germany

  • Investigational Site Number : 2760003

    RECRUITING

    Hanover, 30625, Germany

  • Investigational Site Number : 2760006

    RECRUITING

    Dresden, 01307, Germany

  • Investigational Site Number : 3000001

    RECRUITING

    Heraklion, 711 10, Greece

  • Investigational Site Number : 3000002

    RECRUITING

    Athens, 115 27, Greece

  • Investigational Site Number : 3000003

    RECRUITING

    Ioannina, 455 00, Greece

  • Investigational Site Number : 3480001

    RECRUITING

    Budapest, 1085, Hungary

  • Investigational Site Number : 3800001

    RECRUITING

    Brescia, 25123, Italy

  • Investigational Site Number : 3800002

    RECRUITING

    Florence, Firenze, 50134, Italy

  • Investigational Site Number : 3800003

    RECRUITING

    Naples, Napoli, 80131, Italy

  • Investigational Site Number : 4840001

    RECRUITING

    Mexico City, Mexico City, 14080, Mexico

  • Investigational Site Number : 4840003

    RECRUITING

    Monterrey, Nuevo León, 64460, Mexico

  • Investigational Site Number : 4840005

    RECRUITING

    Mexico City, Mexico City, 06720, Mexico

  • Investigational Site Number : 5280001

    RECRUITING

    Amsterdam, 1105 AZ, Netherlands

  • Investigational Site Number : 6160001

    RECRUITING

    Lodz, Lódzkie, 02-213, Poland

  • Investigational Site Number : 6160002

    RECRUITING

    Opole, Opole Voivodeship, 45-418, Poland

  • Investigational Site Number : 6160004

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-780, Poland

  • Investigational Site Number : 6200002

    RECRUITING

    Porto, 4434-502, Portugal

  • Investigational Site Number : 6200003

    RECRUITING

    Lisbon, 1050-099, Portugal

  • Investigational Site Number : 7030001

    RECRUITING

    Martin, 036 01, Slovakia

  • Investigational Site Number : 7030003

    RECRUITING

    Banská Bystrica, 975 17, Slovakia

  • Investigational Site Number : 7030004

    RECRUITING

    Bratislava - Kramare, 831 01, Slovakia

  • Investigational Site Number : 7240001

    RECRUITING

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240002

    RECRUITING

    Córdoba, 14004, Spain

  • Investigational Site Number : 7240005

    RECRUITING

    Seville, Sevilla, 41013, Spain

  • Investigational Site Number : 7240007

    RECRUITING

    Madrid, 28040, Spain

  • Investigational Site Number : 7240008

    RECRUITING

    Madrid, 28007, Spain

  • Investigational Site Number : 7920001

    RECRUITING

    İzmit, 41001, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    RECRUITING

    Kayseri, 38039, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    RECRUITING

    Leicester, Leicestershire, LE5 4PW, United Kingdom

  • Investigational Site Number : 8260004

    RECRUITING

    Salford, Manchester, M6 8HD, United Kingdom

  • Investigational Site Number : 8260005

    RECRUITING

    Oxford, Oxfordshire, OX3 7LE, United Kingdom

  • Investigational Site Number : 8400001

    RECRUITING

    New York, New York, 10032, United States

  • Investigational Site Number : 8400005

    RECRUITING

    El Paso, Texas, 79902, United States

  • Investigational Site Number : 8400007

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • Investigational Site Number : 8400010

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Investigational Site Number : 8400012

    RECRUITING

    San Francisco, California, 94143, United States

  • Investigational Site Number : 8400014

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Investigational Site Number : 8400015

    RECRUITING

    Orange, California, 92868, United States

  • Investigational Site Number : 8400017

    RECRUITING

    Hinsdale, Illinois, 60521, United States

  • Investigational Site Number : 8400018

    RECRUITING

    Las Vegas, Nevada, 89107, United States

  • Investigational Site Number : 8400019

    RECRUITING

    Edina, Minnesota, 55435, United States

  • Investigational Site Number : 8400021

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Investigational Site Number : 8400024

    RECRUITING

    Dallas, Texas, 75204, United States

  • Investigational Site Number : 8400025

    RECRUITING

    Tampa, Florida, 33612, United States

  • Investigational Site Number: 0760004

    RECRUITING

    Botucatu, São Paulo, 18618-970, Brazil

  • Investigational Site Number: 8400016

    RECRUITING

    Houston, Texas, 77054, United States

  • Investigational Site Number: 8400028

    RECRUITING

    Albuquerque, New Mexico, 87109, United States

  • Synvia Clinical- Site Number : 0760005

    RECRUITING

    São Paulo, São Paulo, 01139-000, Brazil

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