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
Sanofi
526 participants
Mar 13, 2026
INTERVENTIONAL
Conditions
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
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Pharmaceutical form:Solution for injection-Route of administration:IV
Pharmaceutical form:Solution for injection-Route of administration:SC
Pharmaceutical form:Capsule-Route of administration:Oral
Pharmaceutical form:Solution for injection-Route of administration:IV
Pharmaceutical form:Tablet or capsule-Route of administration:Oral
Pharmaceutical form:Tablet-Route of administration:Oral
Pharmaceutical form:Solution for injection-Route of administration:IV
Pharmaceutical form:Tablet-Route of administration:Oral
Locations(26)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07412470