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New drug frexalimab aims to outperform tacrolimus in kidney transplants

NCT ID NCT07412470

First seen Feb 19, 2026 · Last updated Jun 20, 2026 · Updated 15 times

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.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Study site

    RECRUITING

    Torette, Ancona, 60020, Italy

  • 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 : 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 : 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

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.

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.