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NCT01064791 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 298
- Enrollment target
NCT01064791: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01064791 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 298 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (124% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01064791, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 298 participants
- Enrollment target
Study Summary
This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo renal transplantation.
Interventions
- DRUG sotrastaurin (Dose 1) + tacrolimus + standard of care medications
- DRUG sotrastaurin (Dose 2) + tacrolimus + standard of care medications
- DRUG sotrastaurin (Dose 3) + tacrolimus + standard of care medications
- DRUG mycophenolic acid + tacrolimus + standard of care medications
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
What the finished NCT01064791 record still lists
NCT01064791 is an interventional study that assigns participants to a tested intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (124% higher).
The record links to 0 conditions, and to 4 interventions - of which sotrastaurin (Dose 1) + tacrolimus + standard of care medications is the first listed.
NCT01064791 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01064791 about?
NCT01064791 is a clinical study titled "Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients". This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo renal transplantation.
What is the current status of trial NCT01064791?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 298 participants. The study started on 2009-12. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01064791?
The interventions under investigation include: sotrastaurin (Dose 1) + tacrolimus + standard of care medications (DRUG), sotrastaurin (Dose 2) + tacrolimus + standard of care medications (DRUG), sotrastaurin (Dose 3) + tacrolimus + standard of care medications (DRUG), mycophenolic acid + tacrolimus + standard of care medications (DRUG).
Who is sponsoring clinical trial NCT01064791?
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 NCT01064791's enrollment target sits among peer trials
298 188th of 2000 higher than 1,813 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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