Trials / Completed
CompletedNCT00717470
A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection
A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf®-/Advagraf®-Based Immunosuppressive Regimen in Kidney Transplant Subjects (OSAKA Study)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,252 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Prograf® | oral |
| DRUG | Advagraf® | oral |
| DRUG | Mycophenolate Mofetil | oral |
| DRUG | Simulect | oral |
| DRUG | methylprednisolone / prednisone | oral |
Timeline
- Start date
- 2008-05-14
- Primary completion
- 2010-03-02
- Completion
- 2010-03-02
- First posted
- 2008-07-17
- Last updated
- 2024-11-01
Locations
110 sites across 22 countries: Argentina, Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00717470. Inclusion in this directory is not an endorsement.