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NCT00629122 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetics of Sublingual Versus Oral Tacrolimus in Patients Awaiting Kidney Transplantation
A Phase 4 study of Kidney Failure, Chronic, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT00629122 is a Phase 4 study of Kidney Failure, Chronic that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 5 participants, below the 332-participant average among 23 other Kidney Failure, Chronic trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00629122, a Phase 4 study of Kidney Failure, Chronic, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
Tacrolimus (Prograf) belongs to a class of medications known as the calcineurin inhibitors. It is a maintenance drug that is used to prevent rejection in kidney, liver, and heart transplant recipients. Calcineurin inhibitors display high pharmacokinetic (the body's effects on a drug) variability and necessitate use of blood tests to ensure that adequate drug levels are present to maintain effectiveness and safety. Early after transplant or at times when tacrolimus cannot be taken by mouth, alternative routes of administration are sought. Although an intravenous (through the vein) product is available, it can be toxic to the kidneys and has been associated with allergic reactions. Drug delivery via the oral mucosa is an alternative method of systemic drug administration which offers an alternative when oral administration is impractical (gastrointestinal dysmotility, reduced drug absorption, intestinal failure, difficulty in swallowing, or in those with nausea or vomiting). Administration of tacrolimus by the sublingual route may allow for direct entry into the systemic circulation and bypasses problems associated with drug absorption and breakdown that take place in the small intestine.
Conditions Studied
Interventions
- DRUG Tacrolimus (Arm B)
- DRUG Clotrimazole Troche
- DRUG Tacrolimus (Arm A)
- DRUG Nystatin Suspension
Study Locations (1)
New York
- NewYork-Presbyterian Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2008-02 |
| Est. Completion | 2009-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00629122
The ClinicalTrials.gov registry entry for NCT00629122 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 332-participant average among 23 other Kidney Failure, Chronic trials with a reported enrollment target (98% lower). The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Kidney Failure, Chronic appearing as the primary indexed condition, and to 4 interventions - of which Tacrolimus (Arm B) is the first listed.
NCT00629122 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT00629122 about?
NCT00629122 is a clinical study titled "Pharmacokinetics of Sublingual Versus Oral Tacrolimus in Patients Awaiting Kidney Transplantation". Tacrolimus (Prograf) belongs to a class of medications known as the calcineurin inhibitors. It is a maintenance drug that is used to prevent rejection in kidney, liver, and heart transplant recipients. Calcineurin inhibitors display high pharmacokinetic (the body's effects on a drug) variability and...
What is the current status of trial NCT00629122?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2008-02. Estimated completion is 2009-12.
What conditions does trial NCT00629122 study?
This clinical trial studies the following conditions: Kidney Failure, Chronic.
What interventions are being tested in trial NCT00629122?
The interventions under investigation include: Tacrolimus (Arm B) (DRUG), Clotrimazole Troche (DRUG), Tacrolimus (Arm A) (DRUG), Nystatin Suspension (DRUG).
Who is sponsoring clinical trial NCT00629122?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00629122 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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