Trials / Completed
CompletedNCT01410162
Advagraf/Prograf Conversion Trial
A Randomized, Open Label, Cross Over Study to Examine the Impact of Prograf and Advagraf on Tacrolimus Exposure, Mycophenolic Acid Pharmacokinetics, Renal Allograft Function or Adverse Effects.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Norman Muirhead · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Renal and kidney pancreas transplant patients will be randomized to once daily Advagraf or twice daily Prograf to assess changes in tacrolimus and mycophenolate mofetil exposure, renal allograft function, other relevant biochemical parameters and treatment related adverse effects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tacrolimus | tacrolimus extended release capsules vs Prograf |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2014-02-01
- Completion
- 2014-12-01
- First posted
- 2011-08-04
- Last updated
- 2015-09-01
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT01410162. Inclusion in this directory is not an endorsement.