Experience with Alemtuzumab (Campath-1H) as induction agent in renal transplantation followed by steroid-free immunosuppression.

BACKGROUND

The purpose of this study was to describe the initial experience with alemtuzumab as induction followed by steroid-free immunosuppression in kidney transplantation.

METHODS

One hundred patients who received renal transplants from living and deceased donors were followed for a median period of 12 months (range = 1 to 12). A 30-mg intravenous dose of Alemtuzumab was administered on the transplant day, preceded by a 500-mg methylprednisolone dose. Maintenance immunosuppression consisted in the use of a calcineurin inhibitor in association with mycophenolic acid. Maintenance C2 levels of cyclosporine were between 400 and 600 ng/dL; or of tacrolimus, between 4 and 7 ng/dL. Prophylaxis included valgancyclovir, trimethoprim-sulfamethoxasole, and nystatin. All patients were evaluated for acute rejection episodes, adverse events, or death.

RESULTS

The cumulative incidences of acute rejection at 1, 3, 6, and 12 months were 0%, 4% (n = 4), 5% (n = 5), and 8% (n = 8), respectively. Most episodes were Banff 1 a or b (88%). The infectious complication rate was 23%. There was no case of cytomegalovirus infection or posttransplant lymphoproliferative disease. Three patients died: one due to tuberculosis; one, sepsis; and one, an acute coronary event. No patient was lost to follow-up.

CONCLUSIONS

This study suggested the safety and efficacy of Campath-1H as an induction agent in renal transplant recipients.