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Study identifier: NCT07412470 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Kidney Transplant Rejection  ·  Sponsor: Sanofi

PhasePhase 2/Phase 3
Planned participants526
Who can joinAll sexes, 18 Years to 70 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Trial Transparency email recommended (Toll free for US & Canada)  ·  800-633-1610  ·  Contact-US@sanofi.com

Always discuss trial participation with your own doctor first.

Locations (26)

Brigham & Women's Hospital- Site Number : 8400049Boston, Massachusetts, United StatesRecruiting
Montefiore Medical Center - Moses Campus- Site Number : 8400006The Bronx, New York, United StatesRecruiting
Investigational Site Number : 0320001Corrientes, ArgentinaRecruiting
Investigational Site Number : 0360002Adelaide, South Australia, AustraliaRecruiting
Investigational Site Number : 0360001Parkville, Victoria, AustraliaRecruiting
Investigational Site Number : 0360003Sydney, AustraliaRecruiting
Investigational Site Number : 0560002Brussels, BelgiumRecruiting
Investigational Site Number : 1520005Santiago, Reg Metropolitana de Santiago, ChileRecruiting
Investigational Site Number : 1520004Santiago, Reg Metropolitana de Santiago, ChileRecruiting
Investigational Site Number : 1560003Chengdu, ChinaRecruiting
Investigational Site Number : 1560012Jinan, ChinaRecruiting
Investigational Site Number : 1560017Nanchang, ChinaRecruiting

+ 14 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07412470