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RecruitingPhase 2/Phase 3

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

Sanofi · NCT07412470

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
526
US sites recruiting
14
Study start
March 13, 2026
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Frexalimab; Frexalimab; Tacrolimus; rabbit anti-thymocyte globulin; mycophenolate mofetil; mycophenolate sodium; methylprednisolone; prednisone

Conditions: Kidney Transplant Rejection

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

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

    San Francisco, CA 94143

  • Emory University Hospital- Site Number : 8400002

    Atlanta, GA 30324

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

    Hines, IL 60141

  • University of Kansas Medical Center- Site Number : 8400044

    Kansas City, KS 66160

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

    Baltimore, MD 21201

  • Brigham & Women's Hospital- Site Number : 8400049

    Boston, MA 02115

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

    Ann Arbor, MI 48109

  • The Mount Sinai Hospital- Site Number : 8400027

    New York, NY 10029

  • Columbia University Irving Medical Center- Site Number : 8400007

    New York, NY 10032

  • Weill Cornell Medical College- Site Number : 8400005

    New York, NY 10065

  • Montefiore Medical Center - Moses Campus- Site Number : 8400006

    The Bronx, NY 10467

  • The Ohio State University- Site Number : 8400025

    Columbus, OH 43210

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

    Richmond, VA 23298

  • University of Washington Medical Center- Site Number : 8400035

    Seattle, WA 98195

Study contacts (from the official record)

  • Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · Contact-US@sanofi.com
A Study to Investigate the Efficacy and Safety of Frexalimab… (NCT07412470) | Bored Studies