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A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
Sponsor: Sanofi
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.
Official title: A Seamless Phase 2/3 Randomized, Open-label Study to Investigate Efficacy and Safety of Frexalimab Versus Tacrolimus in Adult Kidney Transplant Recipients
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
526
Start Date
2026-03-13
Completion Date
2033-08-15
Last Updated
2026-05-20
Healthy Volunteers
No
Conditions
Interventions
Frexalimab
Pharmaceutical form:Solution for injection-Route of administration:IV
Frexalimab
Pharmaceutical form:Solution for injection-Route of administration:SC
Tacrolimus
Pharmaceutical form:Capsule-Route of administration:Oral
rabbit anti-thymocyte globulin
Pharmaceutical form:Solution for injection-Route of administration:IV
mycophenolate mofetil
Pharmaceutical form:Tablet or capsule-Route of administration:Oral
mycophenolate sodium
Pharmaceutical form:Tablet-Route of administration:Oral
methylprednisolone
Pharmaceutical form:Solution for injection-Route of administration:IV
prednisone
Pharmaceutical form:Tablet-Route of administration:Oral
Locations (16)
Investigational Site Number : 0360001
Parkville, Victoria, Australia
Investigational Site Number : 0360003
Sydney, Australia
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1560003
Chengdu, China
Investigational Site Number : 1560012
Jinan, China
Investigational Site Number : 1560017
Nanchang, China
Investigational Site Number : 1560008
Nanning, China
Investigational Site Number : 1560001
Shanghai, China
Investigational Site Number : 1560006
Wuhan, China
Investigational Site Number : 2080001
Aarhus, Denmark
Investigational Site Number : 3760002
Ramat Gan, Israel
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240007
Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240003
L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain
Investigational Site Number : 7240005
Málaga, Spain
Investigational Site Number : 8260001
Birmingham, England, United Kingdom