| Company Name | Astellas Pharma Taiwan, Inc. |
|---|---|
| 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 |
