NCT07412470

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

A Seamless Phase 2/3 Randomized, Open-label Study to Investigate Efficacy and Safety of Frexalimab Versus Tacrolimus in Adult Kidney Transplant Recipients

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 526 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplant Rejection

Interventions

Type	Name	Description
DRUG	Frexalimab	Pharmaceutical form:Solution for injection-Route of administration:IV
DRUG	Frexalimab	Pharmaceutical form:Solution for injection-Route of administration:SC
DRUG	Tacrolimus	Pharmaceutical form:Capsule-Route of administration:Oral
DRUG	rabbit anti-thymocyte globulin	Pharmaceutical form:Solution for injection-Route of administration:IV
DRUG	mycophenolate mofetil	Pharmaceutical form:Tablet or capsule-Route of administration:Oral
DRUG	mycophenolate sodium	Pharmaceutical form:Tablet-Route of administration:Oral
DRUG	methylprednisolone	Pharmaceutical form:Solution for injection-Route of administration:IV
DRUG	prednisone	Pharmaceutical form:Tablet-Route of administration:Oral

Timeline

• Start date: 2026-03-13
• Primary completion: 2029-08-15
• Completion: 2033-08-15
• First posted: 2026-02-17
• Last updated: 2026-03-27

Locations

2 sites across 2 countries: Australia, China

Regulatory

• FDA-regulated drug study