Two doses of daclizumab in conjunction with low-dose cyclosporine, mycophenolate mofetil and steroids resulted in a low incidence of acute rejection after renal transplantation.

Five doses of daclizumab, given initially after kidney transplantation, reduce the rate of acute rejection (AR). Without cyclosporin A (CsA), a protocol, including daclizumab, mycophenolate mofetil (MMF) and corticosteroids (CSs), has recently shown efficacy in terms of graft function and survival. The rate of AR was relatively high, however. In this single-centre study, a CsA low-dose regimen was combined with two doses of daclizumab (1 mg/kg day 0 and 14), plus MMF (2 g) and CS. Forty-three cadaver donor renal recipients were included. Following the onset of graft function, target trough levels of CsA were 150-200 ng/ml for 90 days, then 100-150 ng/ml. One year AR rate was 23% (n = 10) and events occurred at a median of 2.9 months (range from 9 days to 9.6 months). Delayed graft function (DGF) (absent spontaneous reduction of serum creatinine day 1) was 51%. Graft survival was 95% and patient survival 98% after 1 year. With respect to our previous experience, we used CsA, azathioprine and CSs (n = 223) from 1988 to 1995, and the rate of AR was 57%. From 1996 to 1998, standard CsA doses, MMF and CS (n = 67) resulted in 31% AR. Median time to AR was 0.8 and 1.0 month, and the rate of DGF was 20 and 22%, respectively. This CsA low-dose protocol, including two doses of daclizumab, MMF and CS, resulted in a reduction and delay of AR episodes and excellent graft function, graft survival and patient survival, despite an increase in DGF.