Efficacy and Safety of Combination Therapy With Tacrolimus and Sirolimus in Immunological High Risk Kidney Transplant Recipients.

Abstract

Objective: The aim of this study was to evaluate the efficacy and safety of combination therapy with tacrolimus and sirolimus in immunological high risk recipients. Methods: From January 2010 to December 2011, 28 immunological high risk patients were enrolled according to the following criteria: 1) retransplantation, 2) Class I or II PRA >50%, 3) 5 or 6 HLA mismatches The efficacy endpoints were incidence of biopsy-proven acute rejection reaction, graft loss, patient death and renal function. The safety was evaluated by analyzing the adverse effects. Results: Among 28 total patients, 8 (28.6%) were dropped due to acute rejection, infection, pneumonitis, or postoperative hemorrhage. One patient death occurred due to fungal infection. Acute rejection developed in 6 (21.4%) patients. The mean eGFR (MDRD) for the 1st year after transplantation was 52.0 ± 4.0 mL/min/1.73m2. Fifteen (53.6%) patients had infections and 3 (10.7%) patients experienced pneumonitis. Lymphocele developed in 4 (14.3%) patients. Conclusion: The combination therapy with tacrolimus and sirolimus must be considered with caution for immunological high risk recipients due to high incidence of adverse events. Special attention should be given to the target blood concentration levels of the two drugs in order to minimize adverse events.