Transplantation Proceedings
Volume 35, Issue 3, Supplement , Pages S62-S63, May 2003

Design of a trial comparing sirolimus plus mycophenolate mofetil versus sirolimus plus cyclosporine

  • C Ponticelli

      Affiliations

    • Renal unit Ospedale Maggiore, Milano, Italy (C.P) A.A., A.T.)
    • Corresponding Author InformationAddress reprint requests to Dr Claudio Ponticelli, UO Nefrologia, Ospedale Maggiore Policlinico, Via Commenda 15, 20122 Milano, Italy.
    • ,
  • A Tarantino

      Affiliations

    • Renal unit Ospedale Maggiore, Milano, Italy (C.P) A.A., A.T.)
    • ,
  • A Aroldi

      Affiliations

    • Renal unit Ospedale Maggiore, Milano, Italy (C.P) A.A., A.T.)
    • ,
  • V Sparacino

      Affiliations

    • Ospedale Civico, Palermo, Italy (V.S.)
    • ,
  • S Stefoni

      Affiliations

    • Policlinic University S Orsola, Bologna, Italy (S.S., M.P.S.)
    • ,
  • F Citterio

      Affiliations

    • Department of Surgery, Catholic University, Roma, Italy (F.C.)
    • ,
  • L Duca

      Affiliations

    • Center for Congenital Anemia, Ospedale Maggiore, Milano, Italy (L.D.)
    • ,
  • M.P Scolari

      Affiliations

    • Policlinic University S Orsola, Bologna, Italy (S.S., M.P.S.)
    • ,
  • S Calabrese

      Affiliations

    • Renal unit Ospedale Maggiore, Milano, Italy (C.P) A.A., A.T.)
    • ,
  • P Altieri

      Affiliations

    • Ospedale Brotzu, Cagliari, Italy (P.A.)
    • ,
  • G Civati

      Affiliations

    • Ospedale Civico, Palermo, Italy (V.S.)
    • Ospedale Niguarda, Milano, Italy (G.C.),
    • ,
  • B Cesana

      Affiliations

    • Department of Epidemiology, Ospedale Maggiore, Milano, Italy (B.C.)

Abstract 

We present the study design of a prospective, multicenter, randomized trial aimed at comparing the effects of two different combinations of sirolimus. Renal transplant recipients will be allocated to receive either sirolimus and mycophenolate mofetil (group A) or sirolimus and cyclosporine (group B). The primary endpoint will be the graft function at 3, 6, 12, 24, 36, 48, and 60 months. A number of secondary endpoints will also be considered. To obtain a significant difference in the primary endpoint 180 patients will be enrolled.

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PII: S0041-1345(03)00212-4

doi:10.1016/S0041-1345(03)00212-4

Transplantation Proceedings
Volume 35, Issue 3, Supplement , Pages S62-S63, May 2003

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