Inferior results with basis immunosuppression with sirolimus in kidney transplantation.

BACKGROUND: The introduction of sirolimus has provided the opportunity to develop an immunosuppressive regimen without the nephrotoxic calcineurin inhibitors. METHODS: We conducted a first trial in 30 renal allograft recipients. Ten patients were followed prospectively and received sirolimus, to achieve a target blood level of 10 to 15 ng/ml, induction therapy with one dose of daclizumab, low-dose steroids and mycophenolate mofetil. We compared this group with a historical control group of 20 patients who received our standard treatment consisting of tacrolimus, low-dose steroids, and mycophenolate mofetil. RESULTS: After a mean follow-up of 15 weeks, seven patients developed an acute rejection in the sirolimus group (70%) compared with three patients in the tacrolimus group (15%) (p.