title: Risk factors and outcomes analyses at 36 months of a prospective, randomized, multicenter, trial of daclizumab induction in simultaneous kidney-pancreas transplant recipients.
abstract: The purpose of this study was to analyze risk factors for acute rejection (AR) and long-term outcomes in simultaneous kidney-pancreas transplant (SKPT) patients enrolled in a prospective, multicenter study of daclizumab (DAC) versus no antibody induction.
  
  
  METHODS
  A total of 298 SKPT patients were randomized into three groups and categorized based on an intent to treat analysis, and factors associated with AR and survival were identified using logistic regression and Cox proportional hazards models.
  
  
  RESULTS
  There were no differences in patient or allograft survival or rejection rates among the three groups at 36 months follow-up. Delayed (kidney) graft function (DGF) was a risk factor for subsequent kidney AR (odds ratio = 2.79, P = .002). The presence of kidney AR was also a risk factor (hazard ratio [HR] = 3.1, P = .003) for kidney graft loss, whereas risk factors for pancreas graft loss (censored for graft loss within 30 days or death with functioning graft) included pancreas AR (HR = 1.97, P = .012), kidney AR (HR = 1.61, P = .042), CMV serostatus donor +/recipient - (HR = 1.62, P = .026), and HLA-B mismatch (HR = 1.58, P = .01). Kidney graft loss (HR = 5.5, P = .02) was the only predictor of mortality.
  
  
  CONCLUSIONS
  At 36 months, no significant differences in outcomes were noted in the three study groups. DGF was the major risk factor for kidney AR, kidney AR was the major risk factor for kidney graft loss, and kidney graft loss was the major determinant of mortality. Prevention of kidney DGF and AR in SKPT recipients may play a pivotal role in optimizing long-term outcomes.
authors.affiliation: Dept. of General Surgery, Wake Forest University Baptist Medical Center, Medical Center Boulevard, Winston-Salem, NC 27157-1095, USA. rstratta@wfubmc.edu
authors.forename: R J
authors.initials: RJ
authors.lastname: Stratta
authors.forename: R R
authors.initials: RR
authors.lastname: Alloway
authors.forename: A
authors.initials: A
authors.lastname: Lo
authors.forename: E E
authors.initials: EE
authors.lastname: Hodge
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000077561:Daclizumab; D003922:Diabetes Mellitus, Type 1 / Q000601:surgery; D004305:Dose-Response Relationship, Drug; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000453:epidemiology*; D006650:Histocompatibility Testing; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology / Q000401:mortality / Q000502:physiology*; D016035:Pancreas Transplantation / Q000276:immunology / Q000401:mortality / Q000502:physiology*; D011446:Prospective Studies; D011788:Quality of Life; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D000077561:Daclizumab