Study Comparing Frexalimab Injection Versus Tacrolimus Capsules for Adults Receiving Their First Kidney Transplant

What this Trial Is About

Researchers are evaluating the efficacy and safety of frexalimab compared to tacrolimus in adults undergoing kidney transplantation. This open-label, randomized study focuses on adults aged 18 to 70 who have low-to-moderate immunologic risk of graft rejection and are receiving their first kidney transplant. The trial is designed as a seamless Phase 23 study sponsored by Sanofi, aiming to better understand outcomes related to kidney transplant rejection and graft survival. Participants will receive either frexalimab or tacrolimus as part of their treatment. The first dose of frexalimab will be given intravenously, followed by subcutaneous doses administered via an on-body delivery system. Tacrolimus will be given as capsules orally. The study and treatment duration will be up to approximately 5 years, with about 38 visits planned during this period to monitor participant progress and treatment effects. During the study, participants will undergo various assessments including measurements of kidney function eGFR, proteinuria, incidence of rejection episodes, donor-specific antibodies, and survival rates of both the participant and the graft. Safety will be monitored through reports of adverse events, laboratory tests, vital signs, and device-related events. The primary outcome measure is the composite efficacy failure rate biopsy-proven acute rejection, graft loss, and death within 1 year post-transplantation. Secondary outcomes extend up to 5 years, covering kidney function and cardiovascular health among others. Participants will be closely monitored throughout the trial duration to assess long-term safety and efficacy.

A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation