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 |
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Authors: | Andrés Amado Marcén Roberto Valdés Francisco Plumed Jaime Sánchez Solà Ricard Errasti Pedro Lauzurica Ricardo Pallardó Luis Bustamante Jesús Amenábar Juan José Plaza Juan José Gómez Ernesto Grinyó Josep Maria Rengel Manuel Puig Josep Maria Sanz Aurelio Asensio Concepción Andrés Inés;NIA Study Group |
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Institution: | Hospital 12 de Octubre, Madrid;, Hospital Ramón y Cajal, Madrid;, Hospital Juan Canalejo, A Coruña;, Hospital Universitario La Fe, Valencia;, FundacióPuigvert, Barcelona;, Clínica Universitaria de Navarra, Pamplona;, Hospital Germans Trias i Pujol, Badalona;, Hospital Doctor Peset, Valencia;, Hospital Universitario de Valladolid, Valladolid;, Hospital de Cruces, Barakaldo;, Fundación Jiménez Díaz, Madrid;, Hospital Central de Asturias, Oviedo;, Hospital de Bellvitge, Hospitalet de Llobregat;, Hospital Gregorio Marañón, Madrid;, Hospital del Mar, Barcelona;, Hospital Universitario La Paz, Madrid;and Hospital Virgen de las Nieves, Granada;, Novartis Farmaceutica, S.A., Spain |
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Abstract: | 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 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. |
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Keywords: | acute rejection basiliximab cyclosporin A delayed graft function renal transplant |
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