Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00121784 · ClinicalTrials.gov registry record · Phase 4
Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT00121784 is a Phase 4 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 12 participants.
The verdict
NCT00121784, a Phase 4 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be randomized to either continue this regimen or CNI therapy will be discontinued and replaced by sirolimus therapy (in combination with MMF and corticosteroids). The effect of these 2 regimens on efficacy, safety and renal function will be evaluated.The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.
Interventions
- DRUG mycophenolate mofetil [CellCept]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2005-10 |
| Est. Completion | 2006-08 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00121784
The ClinicalTrials.gov registry entry for NCT00121784 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 12 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 1 intervention - of which mycophenolate mofetil [CellCept] is the first listed.
NCT00121784 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00121784 about?
NCT00121784 is a clinical study titled "Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients". Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be randomized to either continue this regimen or CNI therapy will be discontinued and replaced by sirolimus therapy (in co...
What is the current status of trial NCT00121784?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2005-10. Estimated completion is 2006-08.
What interventions are being tested in trial NCT00121784?
The interventions under investigation include: mycophenolate mofetil [CellCept] (DRUG).
Who is sponsoring clinical trial NCT00121784?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.