A prospective, open-label, randomized, non-inferiority pilot study to compare the dose (6.0mg/kg vs 4.5mg/kg) of antithymocyte globulin as an induction therapy in living donor kidney transplantation

Abstract

The optimal dose of rabbit antithymocyte globulin as an induction regimen in Asian living donor kidney transplant recipients has rarely been investigated. Patients were randomly assigned to receive either 4.5 mg/kg (19 patients) or 6.0 mg/kg (17 patients) antithymocyte globulin. All patients had corticosteroid withdrawal within 7 days. The primary end point was a composite of the biopsy-proven acute rejection, development of de novo donor-specific antibody, or graft failure. At 24 months post-transplant, the composite end point rate was 42.1% in the 4.5 mg/kg group and 24.4% in the 6.0 mg/kg group. There was neither graft failure nor mortality during the follow-up period (22 to 40 months). We decided to stop the study earlier than planned because we were concerned about the higher composite end point rate in the 4.5 mg/kg group. Antithymocyte globulin induction at 4.5 mg/kg and early corticosteroid withdrawal increased the rate of de novo donor-specific antibody and biopsy-proven acute rejection.