Prospective controlled protocol for 3 months steroid withdrawal with tacrolimus, basiliximab, and mycophenolate mofetil in renal transplant recipients

Introduction: During the past few years, the new immunosuppressants such as tacrolimus, mycophenolate mofeti (MMF), and basiliximab, have led to important declines in the incidence of acute rejection and could provide a more potent substrate to attempt safe steroid withdrawal. Methods: We analyzed the clinical outcome of 3 months steroid withdrawal protocol using tacrolimus, MMF, and basiliximab. This 12-month study was an open-label, prospective, controlled clinical trial in a single center. For the patients who entered the protocol, prednisolone was slowly withdrawn by 2.5 mg in every two weeks until 8 weeks after entering the protocol (5 months post-transplantation). Results: Thirty de-novo renal transplant recipients were enrolled. During the steroid withdrawal, 7 patients (26.0%) discontinued the protocol and maintained on steroid treatment. Among 20 patients with the steroid free immunosuppressions with tacolimus and mycophenolate mofetil, 8 patients (40.0%) re-started the steroid. At 12 months after transplantation, patient and graft survival were 100%. Estimated GFR at 3 months, 6 months, and 12 months post-transplantation were 58.9 ± 16.4 mL/min, 53.2 ± 17.9 mL/min, and 49.7 ± 16.0 mL/min, respectively. Conclusions: This study confirms that 3 months steroid withdrawal with tacrolimus, basiliximab, mycophenolate mofetil in kidney transplantation is not associated with increasing mortality or graft loss. Steroid withdrawal after 3 months is a strategy that could be well advised.