A randomized trial of basiliximab with three different patterns of cyclosporin A initiation in renal transplant from expanded criteria donors and at high risk of delayed graft function.

Author(s): Andres A, Marcen R, Valdes F, Plumed JS, Sola R, Errasti P, Lauzurica R, Pallardo L, Bustamante J, Amenabar JJ, Plaza JJ, Gomez E, Grinyo JM, Rengel M, Puig JM, Sanz A, Asensio C, Andres I, NI2A Study Group

Affiliation(s): Nephrology Service, Hospital 12 de Octubre, Madrid, Spain. aandres.hdoc@salud.madrid.org

Publication date & source: 2009-01, Clin Transplant., 23(1):23-32. Epub 2008 Sep 16.

Publication type: Multicenter Study; Randomized Controlled Trial

This study assays therapy with basiliximab and different patterns of cyclosporin A (CsA) initiation in renal transplant (RT) recipients from expanded criteria donors (ECD) and at high risk of delayed graft function (DGF). A multicentre six-month open-label randomized trial with three parallel groups treated with basiliximab plus steroids, mycophenolate mofetil and different patterns of CsA initiation: early within 24 h post-RT at 3 mg/kg/d (Group 1; n = 38), and at 5 mg/kg/d (Group 2; n = 40), or delayed after 7-10 d at 5 mg/kg/d (Group 3; n = 36). There were no differences among groups in six months GFR (43.1 +/- 12, 48.0 +/- 14 and 47.2 +/- 17 mL/min, respectively), DGF (Group 1: 31%, Group 2: 37%, Group 3: 42%), nor biopsy-proven acute rejection, although clinically treated and biopsy-proven acute rejection was significantly higher in Group 3 (25%) vs. Group 1 (5.3%, p < 0.05). At six months no differences were observed in death-censored graft survival or patient survival. Induction therapy with basiliximab and three CsA-ME initiation patterns in RT recipients from ECD and at high risk of DGF presented good renal function and graft survival at six months. Late onset group did not achieve improvement in DGF rate and showed a higher incidence of clinically treated and biopsy-proven acute rejection.