NCT01742676

A Single Center, Open-label, Randomized, Pilot Study to Evaluate the Safety and Efficacy of a Tacrolimus Modified Release, ADVAGRAF®, Versus Tacrolimus Twice Daily, PROGRAF® in Stable Renal Recipients

A Single Center, Open-label, Randomized Pilot Study to Evaluate the Safety and Efficacy of Modified-release Tacrolimus, ADVAGRAF®, Versus Those of Twice-daily Tacrolimus, PROGRAF®, in Stable Renal Recipients (SINGLE)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Astellas Pharma Korea, Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate and compare the safety and efficacy of two drugs (ADVAGRAF® and PROGRAF® groups) in patients who received renal transplantation.

Conditions

• Renal Transplantation
• Kidney Transplantation
• Stable Renal Recipients

Interventions

Type	Name	Description
DRUG	ADVAGRAF	oral
DRUG	PROGRAF	oral

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-12-05
• Last updated: 2014-08-05

Locations

1 site across 1 country: South Korea