PMS Registry
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