title: A single-dose daclizumab induction protocol in renal allograft recipients: a Chinese single center experience.
abstract: This study prospectively compared immunoprophylaxis with a single dose of daclizumab versus no induction in kidney transplant recipients treated with a cyclosporine, mycophenolate mofetil, and prednisone-based immunosuppression regimen seeking to observe the impact of a single-dose regimen for prevention of acute rejection among Chinese renal allograft recipients. A total of 118 renal transplant recipients were randomized into a daclizumab induction therapy group (daclizumab group, n = 58) and a no induction group (control group, n = 60). The daclizumab group received a single-dose (1 mg/kg of ideal body weight by intravenous infusion) 2 hours before the operation. There was no induction therapy in the control group. There was no significant difference in the baseline parameters at randomization between the two groups. The mean time to the first episode of acute rejection was 41.2 +/- 3.2 days for the daclizumab group versus 11.2 +/- 4.6 days for the control group. The number of first biopsy-confirmed acute rejection episodes during the 6-months after transplantation was significantly different in the daclizumab (7,12.1%) versus the control group (14,23.3%; P < .001). At the end of 12 months, patient and graft survivals were 100% in the groups with or without daclizumab. We noted that the incidence of infection, including serious infection was similar, in the daclizumab group to that in the control group, 17.2% and 20.0%, respectively. This study showed that a single-dose of daclizumab effectively prevented acute rejection in Chinese renal allograft recipients.
authors.affiliation: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, 305 East Zhong Shan Road, Nanjing 210002, China. jishuming@vip.163.com
authors.forename: S-M
authors.initials: SM
authors.lastname: Ji
authors.forename: L-S
authors.initials: LS
authors.lastname: Li
authors.forename: Z
authors.initials: Z
authors.lastname: Cheng
authors.forename: D-R
authors.initials: DR
authors.lastname: Cheng
authors.forename: Q-Q
authors.initials: QQ
authors.lastname: Sun
authors.forename: J-S
authors.initials: JS
authors.lastname: Chen
authors.forename: G-Z
authors.initials: GZ
authors.lastname: Sha
authors.forename: Z-H
authors.initials: ZH
authors.lastname: Liu
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D002681:China; D000077561:Daclizumab; D006084:Graft Rejection / Q000453:epidemiology; D006085:Graft Survival / Q000187:drug effects / Q000502:physiology*; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology*; D017741:Survivors; D013601:T-Lymphocytes / Q000187:drug effects / Q000276:immunology; D014184:Transplantation, Homologous
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D000077561:Daclizumab