Despite ever-lower rates of acute rejection and steadily improving short-term graft survival, renal transplantation remains plagued by suboptimal long-term outcomes (1). Improvements in this regard depend on the design and conduct of rigorous studies comparing new to established immunosuppressive regimens. These must be of sufficient duration to directly assess long-term results making trials of this nature time consuming and costly. Given the relatively small patient population served by transplantation, the expense of properly powered registration trials is at times difficult for pharmaceutical companies to justify, particularly when our field has, often by necessity, embraced off-label drug use.
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Newell et al. (2008) studied this question.
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