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

Study on Kidney Transplant Treatments

Recruiting
18 years - 70 years
All
Phase 2/3
526 participants needed
3 Locations

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.

This study investigates kidney transplantation. It evaluates the condition in adults receiving their first kidney transplant.

The study evaluates the effectiveness and safety of an investigational medication compared to another medication. It checks how well the treatments work and how safe they are for participants.

  • Who can participate: Adults aged 18 to 70 receiving their first kidney transplant with low to moderate immunological risk can participate. Certain medical conditions or infections disqualify participation.
  • Study details: Participants will receive either the investigational medication or another treatment. Some participants may receive a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
  • Study timelines and visits: The study will last up to approximately 5 years. The study requires 38 visits.
Updated on 18 Jun 2026. Study ID: NCT07412470

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