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A Randomized, Multicenter Study of Steroid Avoidance, Early Steroid Withdrawal or Standard Steroid Therapy in Kidney Transplant Recipients

In a randomized, open‐label, multicenter study, de novo renal transplant patients received no steroids (n = 112), steroids to day 7 (n = 115), or standard steroids (n = 109) with cyclosporine microemulsion (CsA‐ME), enteric‐coated mycophenolate sodium (EC‐MPS) and basiliximab. The primary objective, to demonstrate noninferiority of 12‐month GFR in the steroid‐free or steroid‐withdrawal groups versus standard steroids, was not met in the intent‐to‐treat population. However, investigational groups were not inferior to standard steroids in the observed‐case analysis. Median 12‐month GFR was not significantly different in the steroid‐free or steroid‐withdrawal groups (58.6 mL/min/1.73 m2 and 59.1 mL/min/1.73 m2) versus standard steroids (60.8 mL/min/1.73 m2). The 12‐month incidence of biopsy‐proven acute rejection (BPAR), graft loss or death was 36.0% in the steroid‐free group (p = 0.007 vs. standard steroids), 29.6% with steroid withdrawal (N.S.) and 19.3% with standard steroids. BPAR was significantly less frequent with standard steroids than either of the other two regimens. Reduced de novo use of antidiabetic and lipid‐lowering medication, triglycerides and weight gain were observed in one or both steroid‐minimization group versus standard steroids. For standard‐risk renal transplant patients receiving CsA‐ME, EC‐MPS and basiliximab, steroid withdrawal by the end of week 1 achieves similar 1‐year renal function to a standard‐steroids regimen, and may be more desirable than complete steroid avoidance.