Trials / Completed
CompletedNCT00195468
Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus
A Randomized, Open-label Study to Compare the Safety and Efficacy of Cyclosporine Dose Reduction With Cyclosporine Elimination in De Novo Renal Allograft Recipients Receiving Rapamune.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Group II).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CYCLOSPORINE |
Timeline
- Start date
- 2004-03-01
- Primary completion
- 2006-11-01
- Completion
- 2006-11-01
- First posted
- 2005-09-19
- Last updated
- 2011-03-08
Locations
13 sites across 2 countries: Brazil, Mexico
Source: ClinicalTrials.gov record NCT00195468. Inclusion in this directory is not an endorsement.