One-year outcomes in simultaneous kidney-pancreas transplant recipients receiving an alternative dosing regimen of daclizumab.

Abstract

UNLABELLED:

The purpose of this study was to compare the safety and efficacy of two dosing regimen of daclizumab with no-antibody induction in simultaneous kidney-pancreas transplant (SKPT) recipients receiving tacrolimus, mycophenolate mofetil, and steroids.

METHODS:

A total of 297 SKPT patients were enrolled into this prospective, multicenter, randomized, open-label study. The patients were randomized into three groups: daclizumab 1 mg/kg/dose every 14 days for five doses (group I, n = 107), daclizumab 2 mg/kg/dose every 14 days for two doses (group II, n = 112), and no-antibody induction (group III, n = 78).

RESULTS:

There were no differences in baseline characteristics among the three groups, except for a higher proportion of African-Americans in group II. The incidence of composite events (acute rejection, graft loss, or death) at 1 year was 36.4%, 32.7%, and 48.7% for groups I, II, and III, respectively (P <.05, group II vs group III). The incidence of acute rejection was highest in group III (34.6%) compared to groups I and II (22.4% and 22.1%, respectively, P <.05). The mean time to acute rejection was delayed in group II (96 days) compared to 23 days in group I and 20 days in group III (P <.05). The adverse-event profiles were comparable among the three groups, except for a higher incidence of infection and readmissions in group III.

CONCLUSIONS:

Daclizumab was safe and effective in reducing the incidence of acute rejection when compared to no induction. The alternative two-dose regimen of daclizumab was as effective as the conventional five-dose regimen and is logistically more desirable.

• Authors: R J Stratta, R R Alloway, A Lo, E E Hodge, PIVOT Study Group
• Journal: Transplantation proceedings (Transplant Proc) Vol. 36 Issue 4 Pg. 1080-1 (May 2004) ISSN: 0041-1345 [Print] United States
• PMID: 15194375 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Immunoglobulin G
• Immunosuppressive Agents
• Daclizumab

Topics

• Antibodies, Monoclonal (administration & dosage, therapeutic use)
• Antibodies, Monoclonal, Humanized
• Daclizumab
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Graft Rejection (epidemiology)
• Humans
• Immunoglobulin G (administration & dosage, therapeutic use)
• Immunosuppressive Agents (administration & dosage, therapeutic use)
• Incidence
• Kidney Transplantation (adverse effects, immunology)
• Pancreas Transplantation (adverse effects, immunology)
• Postoperative Complications (classification, epidemiology)
• Treatment Failure
• Treatment Outcome