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RECRUITING
NCT07412470
PHASE2/PHASE3

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

Sponsor: Sanofi

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.

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

Interventions

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

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