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NCT00765661 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients
A Phase 2 study, sponsored by Veloxis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT00765661: Completed Phase 2 study, sponsored by Veloxis Pharmaceuticals.
NCT00765661 is a Phase 2 study that has completed, run by Veloxis Pharmaceuticals. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00765661, a Phase 2 study, has completed, sponsored by Veloxis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf® capsules, a drug commonly taken by transplant recipients to prevent the body from rejecting a transplanted kidney. LCP-Tacro is a tablet containing the same active ingredient (tacrolimus) that is in Prograf capsules, but the tablet has been designed to release tacrolimus over an extended period so that it only has to be taken once daily. LCP-Tacro is an investigational drug. This study will evaluate the levels of tacrolimus in the blood in the first two weeks after a kidney transplant in patients randomly assigned (by chance, like flipping a coin) to take either LCP-Tacro™ tablets (tacrolimus) once daily or Prograf® capsules twice daily. In addition, patients will remain on study drug for 360 days in order to evaluate the relative safety of LCP-Tacro™ tablets compared to Prograf over a longer period of time.
Primary Outcome
Comparison of the proportion of patients achieving sufficient tacrolimus whole blood trough levels (7 to 20 ng/mL) during the first 14 days post-transplantation
Interventions
- DRUG Prograf
- DRUG Tacrolimus (Tacro™)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2008-09 |
| Est. Completion | 2010-02 |
| Phase | Phase 2 |
What the finished NCT00765661 record still lists
NCT00765661 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Prograf is the first listed.
NCT00765661 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00765661 about?
NCT00765661 is a clinical study titled "Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients". The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf® capsules, a drug commonly taken by transplant recipients to prevent the body from rejecting a transplanted kidney....
What is the current status of trial NCT00765661?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2008-09. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00765661?
The interventions under investigation include: Prograf (DRUG), Tacrolimus (Tacro™) (DRUG).
Who is sponsoring clinical trial NCT00765661?
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 NCT00765661's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 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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