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NCT00817206 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily
A Phase 3 study of Renal Failure, sponsored by Veloxis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 326
- Enrollment target
- 1
- Study location
NCT00817206: Completed Phase 3 study of Renal Failure, sponsored by Veloxis Pharmaceuticals.
NCT00817206 is a Phase 3 study of Renal Failure that has completed, run by Veloxis Pharmaceuticals. The registered enrollment target is 326 participants, above the 272-participant average among 11 other Renal Failure trials with a reported enrollment target (20% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00817206, a Phase 3 study of Renal Failure, has completed, sponsored by Veloxis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 326 participants
- Enrollment target
- 1
- Study location
Study Summary
This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3 controlled trial to establish the efficacy and safety of conversion from maintenance immunosuppressive therapy with Prograf® capsules (tacrolimus, Astellas Pharma US, Inc., Deerfield, IL) twice daily to maintenance immunotherapy with LCP Tacro™ tablets (tacrolimus, LifeCycle Pharma A/S, Hoersholm, Denmark) once daily for the prevention of acute allograft rejection in stable adult kidney transplant patients. Patients on a stable dose of Prograf® will be randomly assigned to be converted from Prograf® twice daily to LCP Tacro™ once daily or to remain on maintenance therapy with Prograf® twice daily. Patients entering the study will be treated with assigned study drug and followed for one year for patient survival and the incidence of graft rejection or graft loss.
Conditions Studied
Interventions
- DRUG LCP-Tacro
- DRUG Prograf
Study Locations (1)
California
- California Institute of Renal Research/ Sharp Memorial - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2008-12 |
| Est. Completion | 2011-02 |
| Phase | Phase 3 |
What the finished NCT00817206 record still lists
NCT00817206 is an interventional study that assigns participants to a tested intervention. The registered 326 participants enrollment target is mid-sized for trials with a published cap, above the 272-participant average among 11 other Renal Failure trials with a reported enrollment target (20% higher).
The record links to 1 condition, with Renal Failure appearing as the primary indexed condition, and to 2 interventions - of which LCP-Tacro is the first listed.
NCT00817206 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00817206 about?
NCT00817206 is a clinical study titled "Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily". This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3 controlled trial to establish the efficacy and safety of conversion from maintenance immunosuppressive therapy with Prograf® capsules (tacrolimus, Astellas Pharma US, Inc., Deerfield, IL) twice daily to maintena...
What is the current status of trial NCT00817206?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 326 participants. The study started on 2008-12. Estimated completion is 2011-02.
What conditions does trial NCT00817206 study?
This clinical trial studies the following conditions: Renal Failure.
What interventions are being tested in trial NCT00817206?
The interventions under investigation include: LCP-Tacro (DRUG), Prograf (DRUG).
Who is sponsoring clinical trial NCT00817206?
This trial is sponsored by Veloxis Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00817206 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Renal Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00817206's enrollment target sits among peer trials
326 3rd of 11 higher than 9 of 11 other Renal Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Failure 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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