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.
• 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.

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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