NCT07412470PHASE2, PHASE3Recruiting

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

Sanofi

Start Date

3/13/2026

Completion Date

8/15/2033

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.

Eligibility Criteria

Age Range: 18 years to 70 years

Inclusion Criteria: * Participants who are scheduled to receive their first kidney transplant from a living or deceased donor. * Participants with low to moderate immunological risk. Exclusion Criteria: * Deceased donor kidney graft qualified as expanded criteria donor or donor after cardiac death. * Positive T or B cell crossmatch, or positive virtual crossmatch per local practice at screening. * Participants receiving a kidney graft from HLA-identical living-related donors, or have current or previous solid organ, cell, or multi-organ transplantation, or paired kidney transplantation. * Participants whose primary causes of ESKD are idiopathic FSGS, C3 glomerulopathy, lupus nephritis, or thrombotic microangiopathy * Evidence of active or latent TB, HIV, HBV or HCV infection. * Participants who have known genetically predisposed thrombophilia, have history of thromboembolic events, or who need long-term anti-coagulation therapy. * Participants who have severe medical co-morbidities, active infection, or severely limited life expectancy due to underlying medical conditions that are generally precluded from kidney transplant. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Interventions

DRUG

Frexalimab

DRUG

Frexalimab

DRUG

Tacrolimus

DRUG

rabbit anti-thymocyte globulin

DRUG

mycophenolate mofetil

DRUG

mycophenolate sodium

DRUG

methylprednisolone

DRUG

prednisone

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Conditions

Kidney Transplant Rejection

Locations

Brigham & Women's Hospital- Site Number : 8400049

Boston, Massachusetts 02115

United States

Montefiore Medical Center - Moses Campus- Site Number : 8400006

The Bronx, New York 10467

United States

Investigational Site Number : 0320001

Corrientes, 3400

Argentina

Investigational Site Number : 0360002

Adelaide, South Australia 5000

Australia

Investigational Site Number : 0360001

Parkville, Victoria 3050

Australia

Investigational Site Number : 0360003

Sydney, 2050

Australia

Investigational Site Number : 0560002

Brussels,

Belgium

Investigational Site Number : 1520005

Santiago, Reg Metropolitana de Santiago 8320325

Chile

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago 8330034

Chile

Investigational Site Number : 1560003

Chengdu, 610041

China

Investigational Site Number : 1560012

Jinan, 250014

China

Investigational Site Number : 1560017

Nanchang, 330006

China

Investigational Site Number : 1560008

Nanning, 530007

China

Investigational Site Number : 1560001

Shanghai, 200127

China

Investigational Site Number : 1560011

Tianjin, 300192

China

Investigational Site Number : 1560006

Wuhan, 430030

China

Investigational Site Number : 1560005

Zhengzhou, 450052

China

Investigational Site Number : 1560009

Zhengzhou, 450061

China

Investigational Site Number : 2080001

Aarhus, 8200

Denmark

Investigational Site Number : 3760002

Ramat Gan, 5262100

Israel

Torette, Ancona 60020

Italy

Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona] 08035

Spain

Investigational Site Number : 7240007

Barcelona, Catalunya [Cataluña] 08036

Spain

Investigational Site Number : 7240003

L'Hospitalet de Llobregat, Catalunya [Cataluña] 08907

Spain

Investigational Site Number : 7240005

Málaga, 29010

Spain

Investigational Site Number : 8260001

Birmingham, England B15 2TH

United Kingdom