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NCT01187953 · ClinicalTrials.gov registry record · Phase 3
Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx
A Phase 3 study, sponsored by Veloxis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 543
- Enrollment target
NCT01187953: Completed Phase 3 study, sponsored by Veloxis Pharmaceuticals.
NCT01187953 is a Phase 3 study that has completed, run by Veloxis Pharmaceuticals. The registered enrollment target is 543 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01187953, a Phase 3 study, has completed, sponsored by Veloxis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 543 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as immunosuppression for the prevention of organ rejection in newly transplanted adult kidney transplant recipients. Patients will be treated for a 12 month study period followed by a 12 month, blinded extension treatment period To show that LCP-Tacro Tablets are clinically similar to Prograf Capsules in the prevention of acute rejection.
Primary Outcome
Treatment failure is a composite endpoint; a patient is considered a treatment failure if the patient experienced any of the following events during this period: death, graft failure, BPAR (Banff grade ≥1A) or lost to follow-up.
Interventions
- DRUG LCP-Tacro
- DRUG Prograf (tacrolimus)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 543 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
What the finished NCT01187953 record still lists
NCT01187953 is an interventional study that assigns participants to a tested intervention. The registered 543 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 (30% lower).
The record links to 0 conditions, and to 2 interventions - of which LCP-Tacro is the first listed.
NCT01187953 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01187953 about?
NCT01187953 is a clinical study titled "Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx". This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as immunosuppression for the prevention of organ rejection in newly transplanted adult kidney transplant recipients. Patients will be treat...
What is the current status of trial NCT01187953?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 543 participants. The study started on 2010-09. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01187953?
The interventions under investigation include: LCP-Tacro (DRUG), Prograf (tacrolimus) (DRUG).
Who is sponsoring clinical trial NCT01187953?
This trial is sponsored by Veloxis Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01187953's enrollment target sits among peer trials
543 694th of 2000 higher than 1,307 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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