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NCT00522548 · ClinicalTrials.gov registry record · Phase 4
Myfortic or CellCept Gastrointestinal Effects in African American Kidney Recipients
A Phase 4 study, sponsored by University of Pennsylvania.
- Terminated
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
NCT00522548: Clinical Trial Phase 4 study, sponsored by University of Pennsylvania.
NCT00522548 is a Phase 4 study that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 37 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00522548, a Phase 4 study, was terminated before completion, sponsored by University of Pennsylvania.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
Study Summary
Myfortic (enteric-coated mycophenolate sodium) has been shown to have similar effectiveness to CellCept (mycophenolate mofetil) in preventing rejection in kidney transplant recipients. However, enteric coated mycophenolate sodium has been thought to possibly be associated with fewer gastrointestinal side effects. Mycophenolate mofetil and enteric coated mycophenolate sodium pharmacokinetics (how the drug is absorbed and broken down) have not been well-studied in African American kidney transplant recipients. The investigators are interested in studying enteric coated mycophenolate sodium and mycophenolate mofetil pharmacokinetics and gastrointestinal side effects in African American kidney transplant recipients.
Interventions
- DRUG Mycophenolate mofetil
- DRUG Enteric coated mycophenolate sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2007-03 |
| Est. Completion | 2011-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00522548
The ClinicalTrials.gov registry entry for NCT00522548 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mycophenolate mofetil is the first listed.
NCT00522548 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00522548 about?
NCT00522548 is a clinical study titled "Myfortic or CellCept Gastrointestinal Effects in African American Kidney Recipients". Myfortic (enteric-coated mycophenolate sodium) has been shown to have similar effectiveness to CellCept (mycophenolate mofetil) in preventing rejection in kidney transplant recipients. However, enteric coated mycophenolate sodium has been thought to possibly be associated with fewer gastrointestinal...
What is the current status of trial NCT00522548?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2007-03. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00522548?
The interventions under investigation include: Mycophenolate mofetil (DRUG), Enteric coated mycophenolate sodium (DRUG).
Who is sponsoring clinical trial NCT00522548?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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