Avtor/Urednik     Grego, K; Arnol, M; Bren, AF; Kmetec, A; Tomažič, J; Kandus, A
Naslov     Basiliximab versus daclizumab combined with triple immunosuppression in deceased donor renal graft recipients
Tip     članek
Vir     Transplant Proc
Vol. in št.     Letnik 39, št. 10
Leto izdaje     2007
Obseg     str. 3093-7
Jezik     eng
Abstrakt     In this prospective, randomized, open-label, single-center study, we compared the efficacy and safety of two anti-interleukin-2 receptor monoclonal antibodies among adult recipients of at least 1 HLA-mismatched deceased donor renal grafts. Eligible patients were randomized to induction with either basiliximab or daclizumab. Both groups received cyclosporine microemulsion (CsA Neoral), mycophenolate mofetil, and methylprednisolone. An intent-to-treat analysis of 1-year data assessed the incidence of acute rejection episodes, the renal graft function, the safety, and the patient and graft survivals. Among 127 patients, six (10.0%) and seven (11.5%) patients experienced biopsy-confirmed acute rejection at 12 months, in the basiliximab and the daclizumab groups, respectively. Two renal grafts were lost in the basiliximab and six in the daclizumab cohort, one of them due to rejection. One basiliximab and two daclizumab patients died. Hospital treatment was required for 25 and 33 infections in basiliximab and daclizumab groups, respectively. One basal cell carcinoma of skin was detected. One hypersensitivity reaction was observed with daclizumab. At 12 months, serum creatinine was 101+/-28 micromol/L with basiliximab and 109+/-41 micromol/L with daclizumab. Patient survival was 98.4% with basiliximab and 96.7% with daclizumab, and graft survival was 96.8% versus 90.8%, respectively. No significant differences were observed between the groups. Basiliximab or daclizumab combined with triple therapy was an efficient and safe immunosuppression strategy, demonstrated with low incidence of acute rejection episodes, an acceptable adverse event profile, excellent graft function, and high survival rates in adult recipients within the first year after deceased donor renal transplantation.
Deskriptorji     ADULT
AGED
ANTIBODIES, MONOCLONAL
CYCLOSPORINE
DRUG THERAPY, COMBINATION
HISTOCOMPATIBILITY TESTING
HOSPITALIZATION
IMMUNOSUPPRESSIVE AGENTS
KIDNEY TRANSPLANTATION
POSTOPERATIVE COMPLICATIONS
RECOMBINANT FUSION PROTEINS
SAFETY
TISSUE DONORS
TREATMENT OUTCOME