Clinical trial

A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients…

NCT00189839 · Astellas Pharma Inc, Industry · Completed

Key facts

NCT number NCT00189839
Title A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation
Official title A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With MMF (Cellcept®) and Steroids in Patients Undergoing Kidney Transplantation
Lead sponsor Astellas Pharma Inc, Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Kidney Transplantation
Intervention type Drug
Interventions tacrolimus
Enrollment 699
Start date Aug 1, 2004
Primary completion Dec 1, 2006
Completion Dec 1, 2006
First posted Sep 19, 2005
Last update posted Jul 9, 2014
Countries Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Finland, France, Germany, Greece, Hungary and 11 more

At a glance

  • No Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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