New drug frexalimab aims to outperform tacrolimus in kidney transplants

NCT ID NCT07412470

Recruiting now Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

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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

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

Study site
RECRUITING

Torette, Ancona, 60020, Italy
Brigham & Women's Hospital- Site Number : 8400049
RECRUITING

Boston, Massachusetts, 02115, United States
Investigational Site Number : 0320001
RECRUITING

Corrientes, 3400, 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, 2050, Australia
Investigational Site Number : 0560002
RECRUITING

Brussels, 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 : 1560003
RECRUITING

Chengdu, 610041, China
Investigational Site Number : 1560005
RECRUITING

Zhengzhou, 450052, China
Investigational Site Number : 1560006
RECRUITING

Wuhan, 430030, China
Investigational Site Number : 1560008
RECRUITING

Nanning, 530007, 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 : 1560017
RECRUITING

Nanchang, 330006, China
Investigational Site Number : 2080001
RECRUITING

Aarhus, 8200, Denmark
Investigational Site Number : 3760002
RECRUITING

Ramat Gan, 5262100, Israel
Investigational Site Number : 7240001
RECRUITING

Barcelona, Barcelona [Barcelona], 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 : 8260001
RECRUITING

Birmingham, England, B15 2TH, United Kingdom
Montefiore Medical Center - Moses Campus- Site Number : 8400006
RECRUITING

The Bronx, New York, 10467, United States

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