Recruiting
Phase 2
Phase 3

Frexalimab vs. Tacrolimus

Sponsor:

Sanofi

Code:

NCT07412470

Conditions

Kidney Transplant Rejection

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Frexalimab

Frexalimab

Tacrolimus

rabbit anti-thymocyte globulin

mycophenolate mofetil

Study Details

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

Study ID

NCT07412470

Start date

Mar 13, 2026

Status verified date

Oct, 2026

Completion date

Aug 15, 2033

Anticipated

Primary completion date

Aug 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

526 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Frexalimab

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

active comparator: Tacrolimus

Tacrolimus

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

Primary outcome measure

  • Composite efficacy failure rate (BPAR, graft loss, and death) by 1 year post kidney transplantation [ Time Frame: by 1 year ]

Central Contacts and Locations

Central contacts

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

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

Locations

University of California San Francisco - Parnassus Heights- Site Number : 8400001

Recruiting

San Francisco, California, United States, 94143

Emory University Hospital- Site Number : 8400002

Recruiting

Atlanta, Georgia, United States, 30324

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

Recruiting

Hines, Illinois, United States, 60141

University of Kansas Medical Center- Site Number : 8400044

Recruiting

Kansas City, Kansas, United States, 66160

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

Recruiting

Baltimore, Maryland, United States, 21201

Brigham & Women's Hospital- Site Number : 8400049

Recruiting

Boston, Massachusetts, United States, 02115

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

Recruiting

Ann Arbor, Michigan, United States, 48109

The Mount Sinai Hospital- Site Number : 8400027

Recruiting

New York, New York, United States, 10029

Columbia University Irving Medical Center- Site Number : 8400007

Recruiting

New York, New York, United States, 10032

Weill Cornell Medical College- Site Number : 8400005

Recruiting

New York, New York, United States, 10065

Montefiore Medical Center - Moses Campus- Site Number : 8400006

Recruiting

The Bronx, New York, United States, 10467

The Ohio State University- Site Number : 8400025

Recruiting

Columbus, Ohio, United States, 43210

VCU Massey Cancer Center: Dalton Oncology Clinic- Site Number : 8400004

Recruiting

Richmond, Virginia, United States, 23298

University of Washington Medical Center- Site Number : 8400035

Recruiting

Seattle, Washington, United States, 98195

More Information

Sponsor

Sanofi

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.