Company Name | Astellas Pharma Taiwan, Inc. |
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Protocol Number | 506-MA-1001 |
Title of Study | A Multi-center, Randomized, Open-label, Pilot and Exploratory Study Investigating Safety and Efficacy in OPTIMIZEd Dosing of Advagraf® Kidney Transplantation in Asia. |
Primary Objective | 1. To compare renal function between patients receiving optimized dose Advagraf®, 52W after kidney transplantation and patients receiving standard dose Advagraf®. 2. To obtain pilot results of safety and efficacy data in optimized dose Advagraf®, 52W after kidney transplantation compared with standard dose Advagraf®. |
Number of Sites | 6 (4 in Korea; 2 in Taiwan) |
Period of Study | From:June 2014 to:December 2016 |
Number of Patients | 79人 |
IRB Approval Date | April 14, 2014 |
Publication Plan / Date | TBC |