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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 is a Phase 3 study that has completed, run by Veloxis Pharmaceuticals. The registered enrollment target is 543 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01187953
The ClinicalTrials.gov registry entry for NCT01187953 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 543 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 LCP-Tacro is the first listed.
NCT01187953 reports 0 study locations.
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.
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