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NCT01025817 · ClinicalTrials.gov registry record · Phase 3
Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 613
- Enrollment target
NCT01025817: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01025817 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 613 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01025817, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 613 participants
- Enrollment target
Study Summary
The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney transplant recipients.
Primary Outcome
Efficacy failure rate used the composite endpoint of: (1) treated biopsy-proven acute rejection (BPAR)\*, (2) graft loss\*\*, (3) participant death or(4) loss to follow-up. \*A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. \*\*Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis.
Interventions
- DRUG Everolimus and tacrolimus
- DRUG mycophenolate mofetil and tacrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 613 participants |
| Start Date | 2010-01 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
What the finished NCT01025817 record still lists
NCT01025817 is an interventional study that assigns participants to a tested intervention. The registered 613 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 2 interventions - of which Everolimus and tacrolimus is the first listed.
NCT01025817 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01025817 about?
NCT01025817 is a clinical study titled "Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients". The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney transplant recipients.
What is the current status of trial NCT01025817?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 613 participants. The study started on 2010-01. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01025817?
The interventions under investigation include: Everolimus and tacrolimus (DRUG), mycophenolate mofetil and tacrolimus (DRUG).
Who is sponsoring clinical trial NCT01025817?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01025817's enrollment target sits among peer trials
613 598th of 2000 higher than 1,403 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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