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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.

12.2.4 Primary Diagnosis 12.2.5 Donor demographics 12.2.6 Donor Viral Status 12.2.7 Surgical Details 12.2.8 Summary of medical history and secondary diagnoses 12.3.1 Tacrolimus administration – Total daily dose 12.3.2 Tacrolimus whole blood trough levels (ng/mL) 12.3.3 Corticosteroid medication – Rejection therapy 12.3.4

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