Clinical trial
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus…
NCT00251004 · Novartis, Industry · Completed
Key facts
| NCT number | NCT00251004 |
|---|---|
| Title | Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients |
| Official title | Efficacy and Safety Study Comparing Concentration-controlled Everolimus in Two Doses (1.5 and 3.0 mg/Day Starting Doses) With Reduced Cyclosporine Versus 1.44 g Mycophenolic Acid (as Sodium Salt) With Standard Dose Cyclosporine in de Novo Renal Transplant Recipients |
| Lead sponsor | Novartis, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Kidney Transplantation, Graft Rejection |
| Intervention type | Drug |
| Interventions | Everolimus, Mycophenolic Acid (MPA), Cyclosporine A (CsA), Basiliximab, Corticosteroids |
| Enrollment | 833 |
| Start date | Oct 1, 2005 |
| Primary completion | Aug 1, 2009 |
| Completion | Oct 1, 2009 |
| First posted | Nov 9, 2005 |
| Last update posted | May 10, 2011 |
| Countries | United States |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: