About this trial
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 criteria
Qualifiers
Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.
Participants with low to moderate immunological risk.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Frexalimab
- Frexalimab
- Tacrolimus
- rabbit anti-thymocyte globulin
- mycophenolate mofetil
- mycophenolate sodium
- methylprednisolone
- prednisone