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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
2026-09-21
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 (63)
Emory University Hospital- Site Number : 8400002
Atlanta, Georgia, United States
Edward Hines, Jr. Veterans Affairs Hospital- Site Number : 8400010
Hines, Illinois, United States
University of Kansas Medical Center- Site Number : 8400044
Kansas City, Kansas, United States
University of Maryland School of Medicine - Baltimore- Site Number : 8400045
Baltimore, Maryland, United States
Brigham & Women's Hospital- Site Number : 8400049
Boston, Massachusetts, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400022
Ann Arbor, Michigan, United States
The Mount Sinai Hospital- Site Number : 8400027
New York, New York, United States
Columbia University Irving Medical Center- Site Number : 8400007
New York, New York, United States
Montefiore Medical Center - Moses Campus- Site Number : 8400006
The Bronx, New York, United States
The Ohio State University- Site Number : 8400025
Columbus, Ohio, United States
University of Washington Medical Center- Site Number : 8400035
Seattle, Washington, United States
Investigational Site Number : 0320002
Buenos Aires, Argentina
Investigational Site Number : 0320001
Corrientes, Argentina
Investigational Site Number : 0360003
Sydney, New South Wales, Australia
Investigational Site Number : 0360002
Adelaide, South Australia, Australia
Investigational Site Number : 0360004
Clayton, Victoria, Australia
Investigational Site Number : 0360001
Parkville, Victoria, Australia
Investigational Site Number : 0560002
Brussels, Belgium
Investigational Site Number : 0560001
Leuven, Belgium
Hospital Geral de Fortaleza - HGF- Site Number : 0760007
Fortaleza, Ceará, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760004
Porto Alegre, Rio Grande do Sul, Brazil
Hospital do Rim e Hipertensão- Site Number : 0760001
São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760006
São Paulo, Brazil
Investigational Site Number : 1520005
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1560018
Beijing, China
Investigational Site Number : 1560003
Chengdu, China
Investigational Site Number : 1560007
Guangzhou, China
Investigational Site Number : 1560020
Guangzhou, China
Investigational Site Number : 1560002
Hangzhou, China
Investigational Site Number : 1560012
Jinan, China
Investigational Site Number : 1560017
Nanchang, China
Investigational Site Number : 1560008
Nanning, China
Investigational Site Number : 1560016
Shanghai, China
Investigational Site Number : 1560001
Shanghai, China
Investigational Site Number : 1560011
Tianjin, China
Investigational Site Number : 1560006
Wuhan, China
Investigational Site Number : 1560005
Zhengzhou, China
Investigational Site Number : 1560009
Zhengzhou, China
Investigational Site Number : 2030002
Ostrava, Czechia
Investigational Site Number : 2030001
Prague, Czechia
Investigational Site Number : 2080001
Aarhus, Denmark
Investigational Site Number : 2500009
Nantes, France
Investigational Site Number : 2500008
Paris, France
Investigational Site Number : 2500001
Toulouse, France
Investigational Site Number : 2500003
Tours, France
Investigational Site Number : 3480001
Pécs, Hungary
Investigational Site Number : 3760002
Ramat Gan, Israel
Investigational Site Number : 3800008
Torette, Ancona, Italy
Investigational Site Number : 3800010
Milan, Milano, Italy
Investigational Site Number : 3800005
Milan, Milano, Italy
Investigational Site Number : 3800006
Rome, Roma, Italy
Investigational Site Number : 3800003
Bologna, Italy
Investigational Site Number : 3800009
Brescia, Italy
Investigational Site Number : 3800011
Novara, Italy
Investigational Site Number : 5280001
Groningen, Netherlands
Investigational Site Number : 5280002
Leiden, Netherlands
Investigational Site Number : 7240001
Barcelona, Catalunya [Cataluña], 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 : 7520001
Gothenburg, Sweden
Investigational Site Number : 8260001
Birmingham, England, United Kingdom