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

NCT07412470 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: EFC185542025-521521-33-002025
• Study Type: interventional
• Target: 526
• Locations: 17 countries
• Sites: 63

Brief 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

Outcome Measures

Primary Outcomes (1)

• Composite efficacy failure rate (BPAR, graft loss, and death) by 1 year post kidney transplantation

  BPAR is defined as biopsy confirmed T cell mediated and antibody mediated rejection as categorized by BANFF 2022; graft loss is defined as the first date the patients meet any of the following criteria: chronic dialysis for a least 56 days, day of allograft nephrectomy, or day of re-transplant.

  by 1 year

Secondary Outcomes (35)

• eGFR at 1 year post kidney transplantation

  at 1 year

• eGFR at 6 months, 2 years, 3 years, 4 years, and 5 years post kidney transplantation

  at 6 months, 2 years, 3 years, 4 years, and 5 years

• Change of eGFR from Month 3 over time up to 5 years post kidney transplantation

  from Month 3 over time up to 5 years

• Participant status of eGFR > 60 mL/min/1.73 m2 at 1, 2, 3, and 5 years post kidney transplantation

  at 1, 2, 3, and 5 years

• Participant status of eGFR < 60 mL/min/1.73 m² at Month 12 or with a > 10 mL/min/1.73 m² decrease in eGFR from Month 3 to 12

  from Month 3 to 12

Study Arms (2)

Frexalimab

EXPERIMENTAL

The first dose of frexalimab will be given intravenously and subsequent doses of frexalimab will be administered subcutaneously via on-body delivery system(OBDS)

Drug: Frexalimab; Drug: rabbit anti-thymocyte globulin; Drug: mycophenolate mofetil; Drug: mycophenolate sodium; Drug: methylprednisolone; Drug: prednisone

Tacrolimus

ACTIVE COMPARATOR

Tacrolimus

Drug: Tacrolimus; Drug: rabbit anti-thymocyte globulin; Drug: mycophenolate mofetil; Drug: mycophenolate sodium; Drug: methylprednisolone; Drug: prednisone

Interventions

methylprednisolone DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV

Frexalimab; Tacrolimus

prednisone DRUG

Pharmaceutical form:Tablet-Route of administration:Oral

Frexalimab; Tacrolimus

Frexalimab DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV

Also known as: SAR441344

Frexalimab

Tacrolimus DRUG

Pharmaceutical form:Capsule-Route of administration:Oral

Tacrolimus

rabbit anti-thymocyte globulin DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV

Frexalimab; Tacrolimus

mycophenolate mofetil DRUG

Pharmaceutical form:Tablet or capsule-Route of administration:Oral

Frexalimab; Tacrolimus

mycophenolate sodium DRUG

Pharmaceutical form:Tablet-Route of administration:Oral

Frexalimab; Tacrolimus

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.
• Participants with low to moderate immunological risk.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (63)

Emory University Hospital- Site Number : 8400002

Atlanta, Georgia, 30324, United States

RECRUITING

Edward Hines, Jr. Veterans Affairs Hospital- Site Number : 8400010

Hines, Illinois, 60141, United States

RECRUITING

University of Kansas Medical Center- Site Number : 8400044

Kansas City, Kansas, 66160, United States

RECRUITING

University of Maryland School of Medicine - Baltimore- Site Number : 8400045

Baltimore, Maryland, 21201, United States

RECRUITING

Brigham & Women's Hospital- Site Number : 8400049

Boston, Massachusetts, 02115, United States

RECRUITING

University of Michigan Health System - Ann Arbor- Site Number : 8400022

Ann Arbor, Michigan, 48109, United States

RECRUITING

The Mount Sinai Hospital- Site Number : 8400027

New York, New York, 10029, United States

RECRUITING

Columbia University Irving Medical Center- Site Number : 8400007

New York, New York, 10032, United States

RECRUITING

Montefiore Medical Center - Moses Campus- Site Number : 8400006

The Bronx, New York, 10467, United States

RECRUITING

The Ohio State University- Site Number : 8400025

Columbus, Ohio, 43210, United States

RECRUITING

University of Washington Medical Center- Site Number : 8400035

Seattle, Washington, 98195, United States

RECRUITING

Investigational Site Number : 0320002

Buenos Aires, 1431, Argentina

RECRUITING

Investigational Site Number : 0320001

Corrientes, 3400, Argentina

RECRUITING

Investigational Site Number : 0360003

Sydney, New South Wales, 2050, Australia

RECRUITING

Investigational Site Number : 0360002

Adelaide, South Australia, 5000, Australia

RECRUITING

Investigational Site Number : 0360004

Clayton, Victoria, 3168, Australia

RECRUITING

Investigational Site Number : 0360001

Parkville, Victoria, 3050, Australia

RECRUITING

Investigational Site Number : 0560002

Brussels, 1200, Belgium

RECRUITING

Investigational Site Number : 0560001

Leuven, 3000, Belgium

RECRUITING

Hospital Geral de Fortaleza - HGF- Site Number : 0760007

Fortaleza, Ceará, 60150-160, Brazil

RECRUITING

Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760004

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

RECRUITING

Hospital do Rim e Hipertensão- Site Number : 0760001

São Paulo, 04038-002, Brazil

RECRUITING

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760006

São Paulo, 05403-000, Brazil

RECRUITING

Investigational Site Number : 1520005

Santiago, Reg Metropolitana de Santiago, 8320325, Chile

RECRUITING

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, 8330034, Chile

RECRUITING

Investigational Site Number : 1560018

Beijing, 100050, China

RECRUITING

Investigational Site Number : 1560003

Chengdu, 610041, China

RECRUITING

Investigational Site Number : 1560007

Guangzhou, 510080, China

RECRUITING

Investigational Site Number : 1560020

Guangzhou, 510280, China

RECRUITING

Investigational Site Number : 1560002

Hangzhou, 310003, China

RECRUITING

Investigational Site Number : 1560012

Jinan, 250014, China

RECRUITING

Investigational Site Number : 1560017

Nanchang, 330006, China

RECRUITING

Investigational Site Number : 1560008

Nanning, 053007, China

RECRUITING

Investigational Site Number : 1560016

Shanghai, 200032, China

RECRUITING

Investigational Site Number : 1560001

Shanghai, 200127, China

RECRUITING

Investigational Site Number : 1560011

Tianjin, 300192, China

RECRUITING

Investigational Site Number : 1560006

Wuhan, 430030, China

RECRUITING

Investigational Site Number : 1560005

Zhengzhou, 450052, China

RECRUITING

Investigational Site Number : 1560009

Zhengzhou, 450061, China

RECRUITING

Investigational Site Number : 2030002

Ostrava, 708 52, Czechia

RECRUITING

Investigational Site Number : 2030001

Prague, 140 21, Czechia

RECRUITING

Investigational Site Number : 2080001

Aarhus, 8200, Denmark

RECRUITING

Investigational Site Number : 2500009

Nantes, 44093, France

RECRUITING

Investigational Site Number : 2500008

Paris, 75015, France

RECRUITING

Investigational Site Number : 2500001

Toulouse, 31059, France

RECRUITING

Investigational Site Number : 2500003

Tours, 37044, France

RECRUITING

Investigational Site Number : 3480001

Pécs, 7624, Hungary

RECRUITING

Investigational Site Number : 3760002

Ramat Gan, 5262100, Israel

RECRUITING

Investigational Site Number : 3800008

Torette, Ancona, 60020, Italy

RECRUITING

Investigational Site Number : 3800010

Milan, Milano, 20122, Italy

RECRUITING

Investigational Site Number : 3800005

Milan, Milano, 20162, Italy

RECRUITING

Investigational Site Number : 3800006

Rome, Roma, 00133, Italy

RECRUITING

Investigational Site Number : 3800003

Bologna, 40138, Italy

RECRUITING

Investigational Site Number : 3800009

Brescia, 25123, Italy

RECRUITING

Investigational Site Number : 3800011

Novara, 28100, Italy

RECRUITING

Investigational Site Number : 5280001

Groningen, 9713 GR, Netherlands

RECRUITING

Investigational Site Number : 5280002

Leiden, 2333 ZA, Netherlands

RECRUITING

Investigational Site Number : 7240001

Barcelona, Catalunya [Cataluña], 08035, Spain

RECRUITING

Investigational Site Number : 7240007

Barcelona, Catalunya [Cataluña], 08036, Spain

RECRUITING

Investigational Site Number : 7240003

L'Hospitalet de Llobregat, Catalunya [Cataluña], 08907, Spain

RECRUITING

Investigational Site Number : 7240005

Málaga, 29010, Spain

RECRUITING

Investigational Site Number : 7520001

Gothenburg, 413 45, Sweden

RECRUITING

Investigational Site Number : 8260001

Birmingham, England, B15 2TH, United Kingdom

RECRUITING

Related Links

• EFC18554 Plain Language Results Summary
• For EU sites click here and navigate to 'Locations and contact points'

MeSH Terms

Interventions

Tacrolimus; Antilymphocyte Serum; Mycophenolic Acid; Methylprednisolone; Prednisone

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: \[Specify Complex Masking\]
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: \[Specify Complex Design\]

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 17, 2026
• Study Start: March 13, 2026
• Primary Completion (Estimated): August 15, 2029
• Study Completion (Estimated): August 15, 2033
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

GB (1); DK (1); ES (4); BE (2); CN (14); AU (4); CL (2); IL (1); AR (2); IT (7); US (11); FR (4); NL (2); SE (1); CZ (2); HU (1); BR (4)