title: High rejection rate during calcineurin inhibitor-free and early steroid withdrawal immunosuppression in renal transplantation.
abstract: Morbidity and mortality due to cardiovascular disease are major problems after renal transplantation. The effects of three immunosuppressive protocols on cardiovascular end points were investigated in a single-center, randomized, parallel (1-1-1) group. Acute rejection was a secondary safety endpoint. Groups were as follows: group one, tacrolimus+sirolimus; group two, tacrolimus+mycophenolate mofetil (MMF); group three, sirolimus+MMF+daclizumab. All groups received two days methylprednisolone only. The Ethical Committee demanded an interim analysis when 50% of the patients were included. In this analysis, 54 patients with a median follow-up of 9.2 months were studied. The Kaplan-Meyer analysis showed a difference in rejection free survival between group one (82%) and group three (34%, P=0.03) and between groups one and two (tacrolimus-based, 76%) and group three (calcineurin-free, 34%, P=0.04). Calcineurin-free immunosuppression with two days of steroids only showed an unacceptable high incidence of acute rejection and re-rejection, and the study had to be stopped.
authors.affiliation: Department of Internal Medicine, University Hospital Maastricht, the Netherlands. mgel@sint.azm.nl
authors.forename: Marielle A C J
authors.initials: MA
authors.lastname: Gelens
authors.forename: Maarten H L
authors.initials: MH
authors.lastname: Christiaans
authors.forename: Ernst L W
authors.initials: EL
authors.lastname: van Heurn
authors.forename: Ella P M
authors.initials: EP
authors.lastname: van den Berg-Loonen
authors.forename: Carine J
authors.initials: CJ
authors.lastname: Peutz-Kootstra
authors.forename: Johannes P
authors.initials: JP
authors.lastname: van Hooff
mesh_terms: D000328:Adult; D065095:Calcineurin Inhibitors; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006084:Graft Rejection / Q000517:prevention & control*; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods*; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use*; D013256:Steroids / Q000627:therapeutic use; D017211:Treatment Failure
chemical_list: D065095:Calcineurin Inhibitors; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D013256:Steroids; D008775:Methylprednisolone