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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSanofi

About this trial

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

Qualifiers

Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.

Participants with low to moderate immunological risk.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Frexalimab
  • Frexalimab
  • Tacrolimus
  • rabbit anti-thymocyte globulin
  • mycophenolate mofetil
  • mycophenolate sodium
  • methylprednisolone
  • prednisone

Treatment groups

526 Participants
are divided into 2 treatment groups

Sponsors and collaborators