Thymoglobulin Induction Therapy in Kidney Transplantation (6mg/kg vs 4mg/kg)

Summary

This is a prospective randomized controlled study to evaluate feasibility and safety of early steroid withdrawal after 6mg/kg vs 4.5mg/kg Thymoglobulin induction therapy in kidney transplantation. Patients are enrolled from June, 2015 for 24 months. They are randomized to either 6mg/kg or 4.5mg/kg Thymoglobulin induction group. Steroid withdrawal is done within one week after kidney transplantation for all the patients. Maintenance immunosuppressants are Tacrolimus and Mycophenolate mofetil (or Myfortic). Primary outcome is a composite of biopsy-proven acute rejection, delayed graft function, graft loss or death within one year post transplant.

Timeline

Start

2015-06

Primary completion

2018-05

Completion

2018-05

Publications

• Ko Y, Wee YM, Shin S, Kim MJ, Choi MY, Kim DH, Lim SJ, Jung JH, Kwon H, Kim YH, Han DJ. A prospective, randomized, non-blinded, non-inferiority pilot study to assess the effect of low-dose anti-thymocyte globulin with low-dose tacrolimus and early steroid withdrawal on clinical outcomes in non-sensitized living-donor kidney recipients. PLoS One. 2023 Mar 1;18(3):e0280924. doi: 10.1371/journal.pone.0280924. eCollection 2023.

Drugs

Indications