RANDOMIZED COMPARISON OF TRIPLE THERAPY AND ANTITHYMOCYTE GLOBULIN INDUCTION TREATMENT AFTER SIMULTANEOUS PANCREAS-KIDNEY TRANSPLANTATION

Background. The incidence of acute rejection is considered to be highe r after simultaneous pancreas-kidney (SPK) transplantation as compared to renal transplant alone. Therefore, the majority of SPK transplant recipients commonly receive a combination of cyclosporine (CsA) or tra colimus, and azathioprine or mycophenolic mofetyl, corticosteroids and /or antilymphocyte preparations. This study was designed to compare tw o immunosuppressive protocols for the prevention of acute rejection in patients undergoing SPK transplantation. The primary end-point was th e incidence of acute rejection during the first 12 months after transp lantation Methods. Fifty patients with type-I insulin-dependent diabet es and chronic renal failure were randomized to receive a triple drug immunosuppressive regimen including CsA, azathioprine and corticostero ids (N = 25), or the quadruple sequential combination of rabbit antith ymocyte globulin (ATG) given fur 10 days, azathioprine, corticosteroid s and delayed CsA (N = 25). Maintenance immunosuppression (CsA and aza thioprine, without corticosteroids) was similar in both arms. Results. The average follow-up was 36 months in both groups (range 9 to 60 mon ths). No patient was excluded from the study. Although the percentage of patients with adverse events was higher in the ATG group (80 vs. 40 %, P < 0.01), none of them resulted in premature discontinuation of th e drug. Patients receiving ATG experienced a lower incidence (36% vs. 76%, P < 0.01) and number (13 vs. 29, P < 0.05) of acute renal rejecti on episodes. However, no difference was observed in patient, pancreas and kidney survival rates between groups. No case of isolated pancreas rejection was observed. Conclusions. The quadruple sequential combina tion ATG, azathioprine, corticosteroid and CsA significantly reduced t he one year incidence of acute renal rejection after SPK transplantati on, compared to a triple immunosuppressive regimen.