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Frexalimab vs. Tacrolimus for Kidney Transplant Patients

This study is testing a new medication called frexalimab against a standard medication, tacrolimus, in adults who are receiving their first kidney transplant. The goal is to see how well frexalimab works and if it's safe in preventing the body from rejecting the new kidney. You might be able to join if you are between 18 and 70 years old, are getting your first kidney transplant, and have a low to moderate risk of your body rejecting the new kidney. The main way we'll know if the study is successful is by looking at how many people experience rejection, graft loss (when the new kidney stops working), or death within one year after their transplant. The current recruitment status is unclear.

Study design
This is an open-label, randomized study comparing frexalimab to tacrolimus. It plans to enroll 526 participants.
What's involved
The study and treatment will last for up to approximately 5 years, with about 38 visits during that time.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures outcomes by 1 year post kidney transplantation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07412470

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

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Sanofi
~526 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:FrexalimabTacrolimusrabbit anti-thymocyte globulinmycophenolate mofetilmycophenolate sodiummethylprednisolone

At a glance

Recruiting sites
26 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite efficacy failure rate (BPAR, graft loss, and death) by 1 year post kidney transplantation
Measured over by 1 year

Conditions

Kidney Transplant Rejection

Explore related trials

Kidney Transplantation

Where it's being run

26 sites across 16 states
China9
Reg Metropolitana de Santiago2
Catalunya [Cataluña]2
Massachusetts1
New York1
Argentina1
South Australia1
Victoria1

Who to contact

Trial Transparency email recommended (Toll free for US & Canada)
[email protected]
800-633-1610 · ext. option 6
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

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

    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.