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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
6.0 mg/kg vs 4.5 mg/kg Thymoglobulin
A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death
Time frame: 12 months after kidney transplantation
Pathologic findings according to Banff 2013 criteria
Time frame: 1 day at the time of biopsy
Overall rate of acute rejection
Time frame: 12 months after kidney transplantation
The rate of steroid-free immunosuppressive regimen
Time frame: 12 months after kidney transplantation
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