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

Amado Andrés, Roberto Marcén, Francisco Valdés, Jaime Sánchez Plumed, Ricard Solà, Pedro Errasti, Ricardo Lauzurica, Luis Pallardó, Jesús Bustamante, Juan José Amenábar, Juan José Plaza, Ernesto Gómez, Josep Maria Grinyó, Manuel Rengel, Josep Maria Puig, Aurelio Sanz, Concepción Asensio, Inés Andrés, J. M. Morales, M. PragaB. Ortuño de Solo, E. Hernández, E. Gonzáles, J. Ortuño, J. Pascual, A. Alonso, C. Fernádez, J. García, M. A. Sánchez, D. Ramos, I. Beneyto, Z. Sainz, L. Guirado, J. M. Díaz, J. Manrique, E. Rossich, A. Hernández, B. Bayés, A. Avila, E. Gavela, A. Sancho, J. L. Gorriz, J. F. Crespo, A. Mendiluce, M. B. Bralo, F. Ortega, A. Suárez, A. Calders, S. Gil-Vernet, J. M. Cruzado, J. Torrás, E. Verde, F. Anaya, R. Amman, J. Soler, M. Mir, F. Escuín, C. Jiménez, C. Sánchez, J. Bravo, A. Osuna

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11 Scopus citations

Abstract

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 3mg/kg/d (Group 1; n = 38), and at 5 mg/kg/d (Group 2; n = 40), or delayed after 7-10d 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 (Group1: 31%, Group 2: 37%, Group3: 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.

Original languageEnglish
Pages (from-to)23-32
Number of pages10
JournalClinical Transplantation
Volume23
Issue number1
DOIs
StatePublished - 2009
Externally publishedYes

Keywords

  • Acute rejection
  • Basiliximab
  • Cyclosporin A
  • Delayed graft function
  • Renal transplantt

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