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NCT00251004 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 833
- Enrollment target
NCT00251004: Completed Phase 3 study, sponsored by Novartis.
NCT00251004 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 833 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00251004, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 833 participants
- Enrollment target
Study Summary
The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.
Primary Outcome
The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. A treated BPAR episode was defined as a biopsy graded IA, IB, IIA, IIB, or III that was treated with anti-rejection therapy. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis a
Interventions
- DRUG Everolimus
- DRUG Corticosteroids
- DRUG Basiliximab
- DRUG Cyclosporine A (CsA)
- DRUG Mycophenolic Acid (MPA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 833 participants |
| Start Date | 2005-10 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
What the finished NCT00251004 record still lists
NCT00251004 is an interventional study that assigns participants to a tested intervention. The registered 833 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Everolimus is the first listed.
NCT00251004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00251004 about?
NCT00251004 is a clinical study titled "Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients". The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.
What is the current status of trial NCT00251004?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 833 participants. The study started on 2005-10. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00251004?
The interventions under investigation include: Everolimus (DRUG), Corticosteroids (DRUG), Basiliximab (DRUG), Cyclosporine A (CsA) (DRUG), Mycophenolic Acid (MPA) (DRUG).
Who is sponsoring clinical trial NCT00251004?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00251004's enrollment target sits among peer trials
833 397th of 2000 higher than 1,604 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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