Clinical Trial

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

Study acronym: FREXERA
Recruiting Phase 2/3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 4 changes
notable Trial sites expanded: 23 -> 26 locations 2026-06-24
notable Trial sites expanded: 16 -> 23 locations 2026-06-06
notable Trial sites expanded: 10 -> 16 locations 2026-05-21
notable Trial sites expanded: 2 -> 10 locations 2026-04-28
Trial Details
NCT Number NCT07412470
Lead Sponsor Sanofi
Conditions Kidney Transplant Rejection
Enrollment 526 participants
Start Date 2026-03-13
Primary Completion 2029-08-15 (estimated)
Study Completion 2033-08-15 (estimated)
Updated on ClinicalTrials.gov 2026-06-23