A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation

Recruiting now · Phase 2/Phase 3

Conditions studied: Kidney Transplant Rejection

In brief

The purpose of this open-label, randomized, active-comparator-controlled study is to determine the efficacy and safety of frexalimab subcutaneous administrations up to 5 years compared to tacrolimus capsules in adults undergoing kidney transplantation. Participants aged 18 to 70 years who have low-to-moderate immunologic risk of graft rejection and receive their first kidney transplant are eligible if they meet all inclusion and no exclusion criteria. Study details include: * The study and treatment duration will be up to approximately 5 years. * The number of visits will be approximately 38.

Key facts

Study ID

NCT07412470

Run by

Sanofi

People needed

526

Starts

2026-03-13

Expected to finish

2033-08-15

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.
• Participants with low to moderate immunological risk.

You may not qualify if…

• 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.

Where it is running

• Brigham & Women's Hospital- Site Number : 8400049 — Boston, Massachusetts, United States (enrolling)
• Montefiore Medical Center - Moses Campus- Site Number : 8400006 — The Bronx, New York, United States (enrolling)
• Investigational Site Number : 0320001 — Corrientes, Argentina (enrolling)
• Investigational Site Number : 0360002 — Adelaide, South Australia, Australia (enrolling)
• Investigational Site Number : 0360001 — Parkville, Victoria, Australia (enrolling)
• Investigational Site Number : 0360003 — Sydney, Australia (enrolling)
• Investigational Site Number : 0560002 — Brussels, Belgium (enrolling)
• Investigational Site Number : 1520005 — Santiago, Reg Metropolitana de Santiago, Chile (enrolling)
• Investigational Site Number : 1520004 — Santiago, Reg Metropolitana de Santiago, Chile (enrolling)
• Investigational Site Number : 1560003 — Chengdu, China (enrolling)
• Investigational Site Number : 1560012 — Jinan, China (enrolling)
• Investigational Site Number : 1560017 — Nanchang, China (enrolling)
• Investigational Site Number : 1560008 — Nanning, China (enrolling)
• Investigational Site Number : 1560001 — Shanghai, China (enrolling)
• Investigational Site Number : 1560011 — Tianjin, China (enrolling)
• Investigational Site Number : 1560006 — Wuhan, China (enrolling)
• Investigational Site Number : 1560005 — Zhengzhou, China (enrolling)
• Investigational Site Number : 1560009 — Zhengzhou, China (enrolling)
• Investigational Site Number : 2080001 — Aarhus, Denmark (enrolling)
• Investigational Site Number : 3760002 — Ramat Gan, Israel (enrolling)
• Study site — Torette, Ancona, Italy (enrolling)
• Investigational Site Number : 7240001 — Barcelona, Barcelona [Barcelona], Spain (enrolling)
• Investigational Site Number : 7240007 — Barcelona, Catalunya [Cataluña], Spain (enrolling)
• Investigational Site Number : 7240003 — L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain (enrolling)
• Investigational Site Number : 7240005 — Málaga, Spain (enrolling)

Full record on ClinicalTrials.gov

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