RecruitingPhase 2Phase 3NCT07412470

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

A Seamless Phase 2/3 Randomized, Open-label Study to Investigate Efficacy and Safety of Frexalimab Versus Tacrolimus in Adult Kidney Transplant Recipients

Sponsor

Sanofi

Enrollment

526 participants

Start Date

Mar 13, 2026

Study Type

INTERVENTIONAL

Conditions

Kidney Transplant Rejection

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

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

Exclusion Criteria8

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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