Steroid Withdrawal Immunosuppression After Renal Transplantation

• the incidence of biopsy-confirmed acute rejection. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  The primary efficacy variable was the incidence of biopsy-confirmed acute rejection.
  
  

• death, graft loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  The secondary efficacy variables included the cumulative incidence of a composite endpoint of death, and graft loss;
  
  
• adverse events and serious adverse events [ Time Frame: 6 months , 12 months ] [ Designated as safety issue: No ]
  The proportion of successfully steroid-withdrawn and steroid-free population at 6 months and at 12 months post-transplantation as well as the safety variables including the incidence of adverse events and serious adverse events, [blood pressure, lipid levels (total cholesterol), BUN (blood urea nitrogen) and blood glucose levels]
  
  

Those patients who fulfill the entry criteria enter in this prospective controlled trial of steroid withdrawal starting at three months after transplantation. The entry criteria include 1) no episode of clinically treated nor biopsy confirmed acute rejection up to entry; 2) serum creatinine level equal to or less than 2 mg/mL on three separate measurements; 3) no proteinuria (urine protein less than 1000 mg/24 hours; 4) tacrolimus trough level > 5 ng/ml without signs of nephrotoxicity; 5) agreement to follow the study protocol.

For the patients who enter into the protocol, prednisolone would be slowly withdrawn by 2.5 mg in every two weeks until 8 weeks after entering the protocol (5 months post-transplantation). The patients visit every week, and they are closely monitored with symptoms and signs, blood cell count, chemistry, and urinalysis.