title: A randomized multicenter trial of OKT3 mAbs induction compared with intravenous cyclosporine in pediatric renal transplantation.
abstract: Acute rejection leading to renal graft failure is more frequent among children. In patients treated with T cell antibody induction, retrospective data from the pediatric registry show a 22% reduction in the risk of graft failure. We conducted a randomized trial (n = 287) using OKT3 mAbs in one (OKT3) arm and intravenous cyclosporine in the other arm (CYS). Maintenance therapy consisted of randomized, double blind Sandimmune or Neoral together with prednisone and either azathioprine (AZA) or mycophenolate mofetil (MMF). Morbidity, mortality, rejection rates and adverse reactions in the two study arms were similar. Through 4 yr, graft failure was 27% in OKT3 and 19% in CYS (p = 0.15). One-year graft survival was 89.1% in OKT3 and 89.2% in CYS (p = .19). In multivariate analysis, OKT3 had a numerically inferior graft survival (RR = 1.4, CI 0.8-2.2, p = 0.22). In OKT3 graft survival was inferior for children aged 6 yr or younger. Our trial demonstrates that the incidence of acute rejection or graft failure in pediatric patients is not improved by OKT3 induction therapy relative to cyclosporine induction.
authors.affiliation: University of Alabama, Birmingham, AL, USA.
authors.forename: Mark R
authors.initials: MR
authors.lastname: Benfield
authors.forename: Amir
authors.initials: A
authors.lastname: Tejani
authors.forename: William E
authors.initials: WE
authors.lastname: Harmon
authors.forename: Ruth
authors.initials: R
authors.lastname: McDonald
authors.forename: Donald M
authors.initials: DM
authors.lastname: Stablein
authors.forename: Matthew
authors.initials: M
authors.lastname: McIntosh
authors.forename: Stephen
authors.initials: S
authors.lastname: Rose
mesh_terms: D000293:Adolescent; D001379:Azathioprine / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D003404:Creatinine / Q000097:blood; D016572:Cyclosporine / Q000627:therapeutic use*; D005260:Female; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000517:prevention & control*; D006085:Graft Survival / Q000276:immunology; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007223:Infant; D016030:Kidney Transplantation / Q000276:immunology*; D008297:Male; D016853:Muromonab-CD3 / Q000627:therapeutic use*; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D011241:Prednisone / Q000627:therapeutic use; D014184:Transplantation, Homologous; D017211:Treatment Failure
chemical_list: D007166:Immunosuppressive Agents; D016853:Muromonab-CD3; D016572:Cyclosporine; D003404:Creatinine; D009173:Mycophenolic Acid; D001379:Azathioprine; D011241:Prednisone