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.
Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.
Participants with low to moderate immunological risk.
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
Parallel
Frexalimab
DrugPharmaceutical form:Solution for injection-Route of administration:IV
Frexalimab
DrugPharmaceutical form:Solution for injection-Route of administration:SC
Tacrolimus
DrugPharmaceutical form:Capsule-Route of administration:Oral
rabbit anti-thymocyte globulin
DrugPharmaceutical form:Solution for injection-Route of administration:IV
mycophenolate mofetil
DrugPharmaceutical form:Tablet or capsule-Route of administration:Oral
mycophenolate sodium
DrugPharmaceutical form:Tablet-Route of administration:Oral
methylprednisolone
DrugPharmaceutical form:Solution for injection-Route of administration:IV
prednisone
DrugPharmaceutical form:Tablet-Route of administration:Oral
Composite efficacy failure rate (BPAR, graft loss, and death) by 1 year post kidney transplantation
BPAR is defined as biopsy confirmed T cell mediated and antibody mediated rejection as categorized by BANFF 2022; graft loss is defined as the first date the patients meet any of the following criteria: chronic dialysis for a least 56 days, day of allograft nephrectomy, or day of re-transplant.
eGFR at 1 year post kidney transplantation
eGFR will be calculated with CKD-EPI 2021 formula, based on the creatinine value, age, and gender of the participant
eGFR at 6 months, 2 years, 3 years, 4 years, and 5 years post kidney transplantation
eGFR will be calculated with CKD-EPI 2021 formula, based on the creatinine value, age, and gender of the participant
Change of eGFR from Month 3 over time up to 5 years post kidney transplantation
Participant status of eGFR > 60 mL/min/1.73 m2 at 1, 2, 3, and 5 years post kidney transplantation
