Prospective Controlled Protocol for Three Months Steroid Withdrawal with Tacrolimus, Basiliximab, and Mycophenolate Mofetil in Renal Transplant Recipients

Abstract

During the past few years, new immunosuppressants, such as tacrolimus, mycophenolate mofetil (MMF) and basiliximab, have been shown to successfully decrease the incidence of acute rejection, possibly acting as potent substrates for safe steroid withdrawal. Therefore, clinical outcome of 3 months steroid withdrawal, while using the above immunosuppressants, was analyzed. Clinical trial registry No. was NCT 01550445. Thirty de novo renal transplant recipients were enrolled, and prednisolone was slowly withdrawn 3 months post-transplantation by 2.5 mg at every two weeks, until 8 weeks. During steroid withdrawal, 10 patients (30.0%) discontinued the protocol and they were maintained on steroid treatment. Among 20 steroid free patients, 8 patients (40.0%) re-started the steroid within 12 months post-transplantation. By the study endpoint, 12 (40%) recipients did not take steroid and survival of patients and grafts was 100%. In conclusion, in kidney transplant patients, 3 months steroid withdrawal while taking tacrolimus, basiliximab and mycophenolate mofetil was not associated with increased mortality or graft loss. Despite various causes of failure of steroid withdrawal during the follow-up period, it is a strategy well advised for kidney transplant recipients with regard to long-term steroid-related complications.

Comparative Effectiveness of Tacrolimus-Based Steroid Sparing versus Steroid Maintenance Regimens in Kidney Transplantation: Results from Discrete Event Simulation

“…Two RCTslasting 1 y and comparing steroid withdrawal at 3 mo to steroid maintenance-found no significant difference in the rates of AR and GL, or in cardiovascular outcomes, new onset diabetes mellitus (NODM), or survival. 10,11 Two other 1-y RCTs compared early (7-day) steroid withdrawal to steroid maintenance, and came to the same conclusion. 12,13 A recent 5-y trial found no difference among African American patients in the rates of AR and NODM between steroid maintenance and rapidwithdrawal regimens.…”