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NCT00337493 · ClinicalTrials.gov registry record · Phase 4
Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 155
- Enrollment target
NCT00337493 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 155 participants.
The verdict
NCT00337493, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 155 participants
- Enrollment target
Study Summary
This study will determine which, if any, allelic variants of mycophenolic acid (MPA) metabolizing enzymes, drug transporters and drug targets are associated with the observed variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage. Patients participating in study ML17225 will be eligible for this pharmacogenetic investigation, and will have one additional blood sample taken during the study. The anticipated time on study treatment in study ML17225 is 1-2 years, and the target sample size is 500+ individuals.
Interventions
- DRUG mycophenolate mofetil [CellCept]
- DRUG Cyclosporine or tacrolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2005-12 |
| Est. Completion | 2008-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00337493
The ClinicalTrials.gov registry entry for NCT00337493 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which mycophenolate mofetil [CellCept] is the first listed.
NCT00337493 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00337493 about?
NCT00337493 is a clinical study titled "Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.". This study will determine which, if any, allelic variants of mycophenolic acid (MPA) metabolizing enzymes, drug transporters and drug targets are associated with the observed variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage. Patients participating in study ML172...
What is the current status of trial NCT00337493?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 155 participants. The study started on 2005-12. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00337493?
The interventions under investigation include: mycophenolate mofetil [CellCept] (DRUG), Cyclosporine or tacrolimus (DRUG).
Who is sponsoring clinical trial NCT00337493?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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