We report on the feasibility of a glucocorticoid-free immunosuppression (sirolimus, low-dose tacrolimus, and daclizumab) in simultaneous islet-kidney transplantation in nine patients with type 1 diabetes. There was one renal primary nonfunction. Renal function (n = 8) as assessed by creatinine and creatinine clearance over time was 103 +/- 6 micromol/L and 64 +/- 6 mL/min/1.73 m(2), respectively. Five out of six patients with >or= 2 islet transplantations became insulin independent. The mean HbA(1c) during the follow-up period for all patients after transplantation is 6.2 +/- 0.9% as compared with 8.7 +/- 1.9% prior to transplant. These results in patients with a median follow-up of 2.3 years suggest that kidney transplantation under a glucocorticoid-free immunosuppression is feasible, and that the rate of insulin independence of 80% can be achieved not only in patients with no or minimal diabetes complications, but also in patients with more advanced late complications and in conjunction with kidney transplantation.