Trials / Completed
CompletedNCT02432053
A Study to Demonstrate Safety and Efficacy of Advagraf in Patients Undergoing Kidney or Liver Transplantation in India
An Open Label, Multi-centre, Prospective Study to Demonstrate Safety and Efficacy of Once Daily Advagraf in Patients Undergoing Kidney or Liver Transplantation in India
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to demonstrate safety and efficacy of once-daily Advagraf in adult population undergoing kidney or liver transplantation in India.
Detailed description
This is a phase IV, multi-centre, open label prospective study of once daily Advagraf in 200 patients undergoing kidney or liver transplantation in India. Adult patients undergoing kidney or liver transplantation and meeting all other eligibility criteria will be enrolled in the study. Enrolled patients will be administered once daily dose of Advagraf for 12 weeks. During these 12 weeks a total of 9 regular visits will be undertaken.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Advagraf |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2013-05-01
- Completion
- 2013-05-01
- First posted
- 2015-05-01
- Last updated
- 2015-05-01
Locations
7 sites across 1 country: India
Source: ClinicalTrials.gov record NCT02432053. Inclusion in this directory is not an endorsement.