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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). 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.
Primary Outcome
At 24 weeks, we assessed the number of patients at this timepoint who required permanent dose decrease or discontinuation of either enteric coated mycophenolate sodium or mycophenolate mofetil or its generic equivalent formulation manufactured by Sandoz related to gastrointestinal toxicity.
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 |
Why NCT00522548 stopped before completion
NCT00522548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Mycophenolate mofetil is the first listed.
NCT00522548 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00522548's enrollment target sits among peer trials
37 1482nd of 2000 higher than 511 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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