Author/Editor     Kandus, Aljoša; Arnol, Miha; Omahen, Katarina; Oblak, Manca; Vidan-Jeras, Blanka; Kmetec, Andrej; Bren, Andrej F
Title     Basiliximab versus daclizumab combined with triple immunosuppression in deceased donor renal transplantation: a prospective, randomized study
Type     članek
Source     Transplantation
Vol. and No.     Letnik 89, št. 8
Publication year     2010
Volume     str. 1022-7
Language     eng
Abstract     Background: In this prospective, randomized, open-label, single-center study, we compared the efficacy and safety of two anti-interleukin-2 receptor monoclonal antibodies combined with triple immunosuppression. Methods: The adult recipients of at least one human leukocyte antigen-mismatched deceased donor renal graft on cyclosporine microemulsion, mycophenolate mofetil, and methylprednisolone were randomized to induction with basiliximab or daclizumab, given in standard doses. An intent-to-treat analysis of 1-year data assessed the incidence of acute rejections, graft function, patient and graft survival, and safety of this therapy. Results: Two hundred twelve patients were studied. At 12 months, 11 (10.3%) and 10 (9.5%) patients experienced biopsy-confirmed first acute rejection in basiliximab and daclizumab groups, respectively. Estimated glomerular filtration rate was 69+/-19 mL/min/1.73 m in the basiliximab and 66+/-21 mL/min/1.73 m in the daclizumab group. Patient survival was 97.2% with basiliximab and 97.1% with daclizumab, and graft survival was 94.4% vs. 90.5%, respectively. Hospital treatment was required for 50 and 59 infections in basiliximab and daclizumab groups, respectively. One renal cell carcinoma of native kidney and one basal cell carcinoma were detected in the basiliximab group, and one melanoma of skin in the daclizumab group. One hypersensitivity reaction was observed with daclizumab. No significant differences were found between the groups. Conclusion: Basiliximab or daclizumab combined with triple therapy was an efficient and a safe immunosuppression strategy, demonstrated with low incidence of acute rejections, excellent graft function, high survival rates, and acceptable adverse event profile in adult recipients within the 1st year after deceased donor renal transplantation.
Descriptors     KIDNEY TRANSPLANTATION
ACUTE DISEASE
ADULT
ANTIBODIES, MONOCLONAL
CYCLOSPORINE
DRUG THERAPY, COMBINATION
GRAFT REJECTION
GRAFT SURVIVAL
IMMUNOSUPPRESSIVE AGENTS
METHYLPREDNISOLONE
MYCOPHENOLIC ACID
PROSPECTIVE STUDIES
RECEPTORS, INTERLEUKIN-2
RECOMBINANT FUSION PROTEINS
TIME FACTORS
TREATMENT OUTCOME