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

RECRUITING
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18 years to 70 years old
This study is NOT accepting healthy volunteers
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.

DRUG: Frexalimab, DRUG: Frexalimab, DRUG: Tacrolimus, DRUG: rabbit anti-thymocyte globulin, DRUG: mycophenolate mofetil, DRUG: mycophenolate sodium, DRUG: methylprednisolone, DRUG: prednisone

Kidney Transplant Rejection

Trial Transparency email recommended (Toll free for US & Canada) - Contact-US@sanofi.com
NCT07412470

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