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New drug frexalimab aims to outperform tacrolimus in kidney transplants

NCT ID NCT07412470

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time

Summary

This study tests whether the drug frexalimab can prevent kidney transplant rejection better than the standard drug tacrolimus. About 526 adults receiving their first kidney transplant will be randomly assigned to one of the two treatments and followed for up to 5 years. The main goal is to see if frexalimab reduces the combined risk of rejection, graft loss, or death within the first year.

What this could mean

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

Active substance
frexalimab
What this could lead to
If successful, frexalimab could offer a new option to prevent kidney transplant rejection, potentially with fewer side effects than current standard treatments.
What could go wrong
This is an early-to-mid-stage trial (phase 2/3) with 526 participants, so results may not confirm long-term safety or effectiveness. Open-label design may introduce bias.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 526 people

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

Started

Mar 2026

Expected to finish

Aug 2033

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

18 to 70 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: * Participants who are scheduled to receive their first kidney transplant from a living or deceased donor. * Participants with low to moderate immunological risk. Exclusion Criteria: * Deceased donor kidney graft qualified as expanded criteria donor or donor after cardiac death. * Positive T or B cell crossmatch, or positive virtual crossmatch per local practice at screening. * Participants receiving a kidney graft from HLA-identical living-related donors, or have current or previous solid organ, cell, or multi-organ transplantation, or paired kidney transplantation. * Participants whose primary causes of ESKD are idiopathic FSGS, C3 glomerulopathy, lupus nephritis, or thrombotic microangiopathy * Evidence of active or latent TB, HIV, HBV or HCV infection. * Participants who have known genetically predisposed thrombophilia, have history of thromboembolic events, or who need long-term anti-coagulation therapy. * Participants who have severe medical co-morbidities, active infection, or severely limited life expectancy due to underlying medical conditions that are generally precluded from kidney transplant. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

transplant rejection

As listed by the trial registrant

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

Kidney transplant rejection

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

    63 sites in 17 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

  • Brigham & Women's Hospital- Site Number : 8400049

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Columbia University Irving Medical Center- Site Number : 8400007

    RECRUITING

    New York, New York, 10032, United States

  • Edward Hines, Jr. Veterans Affairs Hospital- Site Number : 8400010

    RECRUITING

    Hines, Illinois, 60141, United States

  • Emory University Hospital- Site Number : 8400002

    RECRUITING

    Atlanta, Georgia, 30324, United States

  • Hospital Geral de Fortaleza - HGF- Site Number : 0760007

    RECRUITING

    Fortaleza, Ceará, 60150-160, Brazil

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760006

    RECRUITING

    São Paulo, 05403-000, Brazil

  • Hospital do Rim e Hipertensão- Site Number : 0760001

    RECRUITING

    São Paulo, 04038-002, Brazil

  • Investigational Site Number : 0320001

    RECRUITING

    Corrientes, 3400, Argentina

  • Investigational Site Number : 0320002

    RECRUITING

    Buenos Aires, 1431, Argentina

  • Investigational Site Number : 0360001

    RECRUITING

    Parkville, Victoria, 3050, Australia

  • Investigational Site Number : 0360002

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Investigational Site Number : 0360003

    RECRUITING

    Sydney, New South Wales, 2050, Australia

  • Investigational Site Number : 0360004

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Investigational Site Number : 0560001

    RECRUITING

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560002

    RECRUITING

    Brussels, 1200, Belgium

  • Investigational Site Number : 1520004

    RECRUITING

    Santiago, Reg Metropolitana de Santiago, 8330034, Chile

  • Investigational Site Number : 1520005

    RECRUITING

    Santiago, Reg Metropolitana de Santiago, 8320325, Chile

  • Investigational Site Number : 1560001

    RECRUITING

    Shanghai, 200127, China

  • Investigational Site Number : 1560002

    RECRUITING

    Hangzhou, 310003, China

  • Investigational Site Number : 1560003

    RECRUITING

    Chengdu, 610041, China

  • Investigational Site Number : 1560005

    RECRUITING

    Zhengzhou, 450052, China

  • Investigational Site Number : 1560006

    RECRUITING

    Wuhan, 430030, China

  • Investigational Site Number : 1560007

    RECRUITING

    Guangzhou, 510080, China

  • Investigational Site Number : 1560008

    RECRUITING

    Nanning, 053007, China

  • Investigational Site Number : 1560009

    RECRUITING

    Zhengzhou, 450061, China

  • Investigational Site Number : 1560011

    RECRUITING

    Tianjin, 300192, China

  • Investigational Site Number : 1560012

    RECRUITING

    Jinan, 250014, China

  • Investigational Site Number : 1560016

    RECRUITING

    Shanghai, 200032, China

  • Investigational Site Number : 1560017

    RECRUITING

    Nanchang, 330006, China

  • Investigational Site Number : 1560018

    RECRUITING

    Beijing, 100050, China

  • Investigational Site Number : 1560020

    RECRUITING

    Guangzhou, 510280, China

  • Investigational Site Number : 2030001

    RECRUITING

    Prague, 140 21, Czechia

  • Investigational Site Number : 2030002

    RECRUITING

    Ostrava, 708 52, Czechia

  • Investigational Site Number : 2080001

    RECRUITING

    Aarhus, 8200, Denmark

  • Investigational Site Number : 2500001

    RECRUITING

    Toulouse, 31059, France

  • Investigational Site Number : 2500003

    RECRUITING

    Tours, 37044, France

  • Investigational Site Number : 2500008

    RECRUITING

    Paris, 75015, France

  • Investigational Site Number : 2500009

    RECRUITING

    Nantes, 44093, France

  • Investigational Site Number : 3480001

    RECRUITING

    Pécs, 7624, Hungary

  • Investigational Site Number : 3760002

    RECRUITING

    Ramat Gan, 5262100, Israel

  • Investigational Site Number : 3800003

    RECRUITING

    Bologna, 40138, Italy

  • Investigational Site Number : 3800005

    RECRUITING

    Milan, Milano, 20162, Italy

  • Investigational Site Number : 3800006

    RECRUITING

    Rome, Roma, 00133, Italy

  • Investigational Site Number : 3800008

    RECRUITING

    Torette, Ancona, 60020, Italy

  • Investigational Site Number : 3800009

    RECRUITING

    Brescia, 25123, Italy

  • Investigational Site Number : 3800010

    RECRUITING

    Milan, Milano, 20122, Italy

  • Investigational Site Number : 3800011

    RECRUITING

    Novara, 28100, Italy

  • Investigational Site Number : 5280001

    RECRUITING

    Groningen, 9713 GR, Netherlands

  • Investigational Site Number : 5280002

    RECRUITING

    Leiden, 2333 ZA, Netherlands

  • Investigational Site Number : 7240001

    RECRUITING

    Barcelona, Catalunya [Cataluña], 08035, Spain

  • Investigational Site Number : 7240003

    RECRUITING

    L'Hospitalet de Llobregat, Catalunya [Cataluña], 08907, Spain

  • Investigational Site Number : 7240005

    RECRUITING

    Málaga, 29010, Spain

  • Investigational Site Number : 7240007

    RECRUITING

    Barcelona, Catalunya [Cataluña], 08036, Spain

  • Investigational Site Number : 7520001

    RECRUITING

    Gothenburg, 413 45, Sweden

  • Investigational Site Number : 8260001

    RECRUITING

    Birmingham, England, B15 2TH, United Kingdom

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760004

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • Montefiore Medical Center - Moses Campus- Site Number : 8400006

    RECRUITING

    The Bronx, New York, 10467, United States

  • The Mount Sinai Hospital- Site Number : 8400027

    RECRUITING

    New York, New York, 10029, United States

  • The Ohio State University- Site Number : 8400025

    RECRUITING

    Columbus, Ohio, 43210, United States

  • University of Kansas Medical Center- Site Number : 8400044

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Maryland School of Medicine - Baltimore- Site Number : 8400045

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Michigan Health System - Ann Arbor- Site Number : 8400022

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Washington Medical Center- Site Number : 8400035

    RECRUITING

    Seattle, Washington, 98195, United States

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