Trials / Completed
CompletedNCT01011205
Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation
A Multicenter, Three Arm, Randomized, Open Label Clinical Study to Compare Renal Function in Liver Transplant Recipients Receiving an Immunosuppressive Regimen of Advagraf (Immediately or Delayed Post-transplant) and MMF With or Without a Monoclonal Anti-IL2R Antibody (Basiliximab)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 893 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Advagraf | Capsule |
| DRUG | Mycophenolate Mofetil | Solution for infusion |
| DRUG | Basiliximab | IV infusion |
| DRUG | Corticosteroids | IV bolus |
Timeline
- Start date
- 2009-09-30
- Primary completion
- 2013-01-04
- Completion
- 2013-01-04
- First posted
- 2009-11-11
- Last updated
- 2024-11-01
Locations
72 sites across 23 countries: Argentina, Austria, Belarus, Belgium, Brazil, Canada, Colombia, Czechia, Finland, France, Germany, Hungary, Ireland, Italy, Mexico, Poland, Romania, Russia, South Africa, Spain, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01011205. Inclusion in this directory is not an endorsement.