NCT00720265

A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation Patients

A PHASE III, Randomized, Open-Label, Comparative, Multi - Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus) and MR4 (Modified Release Tacrolimus) in de Novo Kidney Transplant Recipients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Prograf	oral
DRUG	MR4	oral

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2008-07-22
• Last updated: 2008-07-22

Locations

2 sites across 1 country: South Korea