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

Study of Two Long-Term Anti-Rejection Treatments After a First Kidney Transplant

Age
18 years - 70 years
Gender
All
Phase
Phase 2/3
Participants needed
526
Locations
2
Find a study site near you

Study Overview

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Kidney Transplant Rejection
  • Age: 18 years - 70 years
  • Gender: All

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.

The purpose of this research study is to learn about the effects and safety of two anti-rejection treatment approaches in adults who are getting their first kidney transplant and are at low-to-moderate risk of rejecting the new kidney.

Participants will receive either an investigational study drug given as an injection under the skin or an approved anti-rejection medicine taken as capsules by mouth.

Who can participate:
Adults aged 18 to 70 who are having their first kidney transplant may be able to participate if they:

  • Are scheduled to receive their first kidney transplant from a living or deceased donor
  • Have a low-to-moderate immune system risk of rejecting the transplanted kidney

Study timeline and visits:
Participation lasts up to 5 years. There will be about 38 study visits.

Updated on 18 Jun 2026. Study ID: NCT07412470

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