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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 is a Phase 2 study that has completed, run by Veloxis Pharmaceuticals. The registered enrollment target is 63 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00765661
The ClinicalTrials.gov registry entry for NCT00765661 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Veloxis Pharmaceuticals, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Prograf is the first listed.
NCT00765661 reports 0 study locations.
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.
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