Trials / Completed
CompletedNCT00481819
A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation
A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With MMF and Steroids in Patients Undergoing Kidney Transplantation and a Pharmacokinetics Study.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 240 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FK506MR | oral |
| DRUG | Prograf | oral |
| DRUG | Mycophenolate Mofetil | oral |
| DRUG | Methylprednisolone | oral |
| DRUG | Prednisolone | oral |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2009-03-01
- Completion
- 2009-03-01
- First posted
- 2007-06-04
- Last updated
- 2016-02-24
Locations
9 sites across 1 country: China
Source: ClinicalTrials.gov record NCT00481819. Inclusion in this directory is not an endorsement.