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Clinical Study Report

Final Report , version , July 22th ,2010 - Report Clinical TRIAL NO: FG-506-02-IT-01 Page 1 of 73 AN OPEN, MULTICENTRE, RANDOMISED, PARALLEL GROUP Study TO COMPARE IN MARGINAL OLD-FOR-OLD RENAL TRANSPLANT PATIENTS THE SAFETY AND EFFICACY OF TWO TREATMENTS: SEQUENTIAL MYCOPHENOLATE MOFETIL / DELAYED TACROLIMUS PLUS STEROIDS VS TACROLIMUS PLUS MYCOPHENOLATE MOFETIL IN PATIENTS REQUIRING INDUCTION WITH ANTI-IL2 MONOCLONAL ANTIBODY SHORT TITLE: TIGRE DOMATA (Trial Italiano Gestione REni DOnatori MArginali in Trapiantati Anziani) Clinical TRIAL NO: FG-506-02-IT-01 EudraCT Number: Clinical Study Report Study Drug Name: Tacrolimus (FK 506) Indication: Renal transplant Document Number/MGC Number: FG-506-02-IT-01 Date of Document: May 26th ,2004 Study Initiation Date: 3rd Quarter 2004 Study Completion Date: 1st Quarter 2008 Responsible Officer or Designee: Dr. and Dr. , Sponsor: Original sponsor was Fujisawa GmbH and following a company merger this became Astellas Europe.

This study was performed in compliance with Good Clinical Practice (GCP). Final Report, version 1.0, July 22 th ,2010 - REPORT CLINICAL TRIAL NO: FG-506-02-IT-01 Page 2 of 73

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