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Andres 2009
ID:
5bfc37177aaac837947f4078
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3 Referencias
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Estudio primario
No clasificado
A randomized study to compare immunosuppression based on basiliximab induction and low initial doses or delayed neoral in kidney transplant recipients at high risk for delayed graft function
Autores
»
Marcen R
,
Andres A
,
Sanchez‐Plumed J
,
Valdes F
,
Errasti P
,
Sola R
Revista
»
Transplant International
Año
»
2005
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Estudio primario
No clasificado
Comparative study of three different patterns of immunosuppression based on induction with basiliximab and low initial doses or delayed initiation of neoral in kidney transplant recipients at high risk of delayed graft function
Autores
»
Andres A
,
Marcen R
,
Sanchez J
,
Valdes F
,
Errasti P
,
Sola R
Revista
»
American Journal of Transplantation
Año
»
2005
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Estudio primario
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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
Autores
»
Andrés A
,
Marcén R
,
Valdés F
,
Plumed JS
,
Solà R
,
Errasti P
,
Lauzurica R
,
Pallardó L
,
Bustamante J
,
Amenábar JJ
,
Plaza JJ
,
Gómez E
,
Grinyó JM
,
Rengel M
,
Puig JM
,
Sanz A
,
Asensio C
,
Andrés I
,
NI2A Study Group
Revista
»
Clinical transplantation
Año
»
2009
Enlaces
»
Pubmed
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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. © 2009 John Wiley & Sons A/S.
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Diseño del estudio
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Ensayo controlado aleatorizado (ECA)