drugset / Trial / NCT00481819

A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation

NCT00481819

Phase 3 Completed 240 enrolled Astellas Pharma Inc
RandomizedParallel-groupOpen-labelPrevention

Summary

The patients about to undergo kidney transplantation will be randomized to one of the following two group: Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment period is 3 months( 12 weeks)

Timeline

Start
2007-07
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tacrolimus Small molecule Oral
Background Methylprednisolone Other / unclassified Oral
Background Mycophenolate Mofetil Small molecule Oral
Background Prednisolone Other / unclassified Oral

Indications

No indication recorded.