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NCT01438710 · ClinicalTrials.gov registry record · Phase 3
Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)
A Phase 3 study, sponsored by Veloxis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 44
- Enrollment target
NCT01438710: Completed Phase 3 study, sponsored by Veloxis Pharmaceuticals.
NCT01438710 is a Phase 3 study that has completed, run by Veloxis Pharmaceuticals. The registered enrollment target is 44 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01438710, a Phase 3 study, has completed, sponsored by Veloxis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 44 participants
- Enrollment target
Study Summary
This study will evaluate and measure symptomatic hand tremor in stable kidney transplant subjects on Prograf or generic tacrolimus maintenance therapy at baseline (pre-conversion) and following conversion to LCP-Tacro. This study will also evaluate the safety of LCP-Tacro compared with Prograf or generic tacrolimus
Primary Outcome
The primary efficacy endpoint is the mean change from baseline (ie Day 7) in the Fahn-Tolosa-Marin Clinical Rating Scale (FTM) for overall tremor score 7 days after (ie, Day 14) LCP-Tacro conversion. The overall FTM score was 0 to 100 where higher scores denoted worst/more severe tremor. Below the mean total score and standard deviation for each treatment is given in addition to the mean change.
Interventions
- DRUG LCP-Tacro
- DRUG Prograf
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-07 |
| Phase | Phase 3 |
What the finished NCT01438710 record still lists
NCT01438710 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which LCP-Tacro is the first listed.
NCT01438710 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01438710 about?
NCT01438710 is a clinical study titled "Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)". This study will evaluate and measure symptomatic hand tremor in stable kidney transplant subjects on Prograf or generic tacrolimus maintenance therapy at baseline (pre-conversion) and following conversion to LCP-Tacro. This study will also evaluate the safety of LCP-Tacro compared with Prograf or ge...
What is the current status of trial NCT01438710?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 44 participants. The study started on 2011-12. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01438710?
The interventions under investigation include: LCP-Tacro (DRUG), Prograf (DRUG).
Who is sponsoring clinical trial NCT01438710?
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 NCT01438710's enrollment target sits among peer trials
44 1874th of 2000 higher than 125 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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