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NCT01950819 · ClinicalTrials.gov registry record · Phase 4
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 2,037
- Enrollment target
NCT01950819: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT01950819 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 2,037 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (293% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01950819, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 2,037 participants
- Enrollment target
Study Summary
This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
Primary Outcome
Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) \< 50 mL/min/1.73m2.
Interventions
- DRUG Corticosteroids
- BIOLOGICAL Induction therapy
- DRUG EVR+rCNI
- DRUG MPA+sCNI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,037 participants |
| Start Date | 2013-12-03 |
| Est. Completion | 2018-01-17 |
| Phase | Phase 4 |
What the finished NCT01950819 record still lists
NCT01950819 is an interventional study that assigns participants to a tested intervention. Its 2,037 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (293% higher).
The record links to 0 conditions, and to 4 interventions - of which Corticosteroids is the first listed.
NCT01950819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01950819 about?
NCT01950819 is a clinical study titled "Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)". This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
What is the current status of trial NCT01950819?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 2,037 participants. The study started on 2013-12-03. Estimated completion is 2018-01-17.
What interventions are being tested in trial NCT01950819?
The interventions under investigation include: Corticosteroids (DRUG), Induction therapy (BIOLOGICAL), EVR+rCNI (DRUG), MPA+sCNI (DRUG).
Who is sponsoring clinical trial NCT01950819?
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 NCT01950819's enrollment target sits among peer trials
2,037 36th of 2000 higher than 1,965 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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