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Outcomes at 3 years of a prospective pilot study of Campath‐1H and sirolimus immunosuppression for renal transplantation

Campath‐1H (alemtuzumab) induction was used for renal transplantation in combination with sirolimus as immunosuppression. We previously reported a high (28%) rate of early rejection with this regimen, and now report 3‐year outcomes. Twenty‐nine patients were recipients of either deceased donor or non‐HLA (Human Leukocyte Antigen) identical living donor primary renal allografts. Clinical parameters including infection, malignancy, kidney function, and kidney histology were followed prospectively for 3 years. Three‐year cumulative graft and patient survival were 96% and 100%, respectively. Twenty patients were maintained on steroid‐free immunosuppressive regimens, and 15 patients were maintained on monotherapy for immunosuppression (12 on sirolimus). No serious infectious complications were observed and two patients developed basal cell skin cancer. The 3‐year results of our initial pilot study demonstrate good graft (96%) and patient (100%) outcomes. Campath‐1H induction has yielded a high proportion of patients maintained on immunosuppressive monotherapy (57%) without serious infectious‐ and no malignancy‐related complications. The reported regimen yielded novel insights into both Campath‐1H and sirolimus therapy in renal transplantation. Because of the higher incidence of early rejection, we recommend a modified strategy of immunosuppression including a brief course of a calcineurin inhibitor. (ClinicalTrials.gov number: NCT00365846, date: 16 August 2006)