Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00658333 · ClinicalTrials.gov registry record · Phase 4
A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT00658333: Clinical Trial Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT00658333 is a Phase 4 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00658333, a Phase 4 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms
Primary Outcome
The primary variable was the response (yes/no) with positive response being defined as an increase of 360 mg/day enteric-coated mycophenolate acid (MPA)from the baseline daily dose, tolerated and maintained for a 4 week duration until the end of the study (Week 6). Tolerability was defined as the overall assessment of improvement or no change in the intensity of physician assessed gastrointestinal (GI) symptoms at end of study as reported on the physician administered evaluation of GI symptomato
Interventions
- DRUG Mycophenolate Mofetil (MMF)
- DRUG Enteric-coated Mycophenolate Acid (EC-MPA)
- DRUG Placebo MMF
- DRUG Placebo EC-MPA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-03 |
| Est. Completion | 2009-03 |
| Phase | Phase 4 |
Why NCT00658333 stopped before completion
NCT00658333 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 4 interventions - of which Mycophenolate Mofetil (MMF) is the first listed.
NCT00658333 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00658333 about?
NCT00658333 is a clinical study titled "A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms". To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms
What is the current status of trial NCT00658333?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2008-03. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00658333?
The interventions under investigation include: Mycophenolate Mofetil (MMF) (DRUG), Enteric-coated Mycophenolate Acid (EC-MPA) (DRUG), Placebo MMF (DRUG), Placebo EC-MPA (DRUG).
Who is sponsoring clinical trial NCT00658333?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00658333's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia