Sanofi
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.
Inclusion Criteria: * Participants who are scheduled to receive their first kidney transplant from a living or deceased donor. * Participants with low to moderate immunological risk. Exclusion Criteria: * 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. * P…
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