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NCT00121810 · ClinicalTrials.gov registry record · Phase 4
Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 305
- Enrollment target
NCT00121810 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 305 participants.
The verdict
NCT00121810, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 305 participants
- Enrollment target
Study Summary
This 2-arm study recruited kidney transplant patients who were receiving standard care of calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily) and corticosteroids. They were either randomized to continue this regimen, or CNI therapy was discontinued and replaced by sirolimus therapy (in combination with CellCept and corticosteroids). The effect of these 2 regimens on efficacy, safety and kidney function was evaluated. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.
Interventions
- DRUG Sirolimus
- DRUG Corticosteroids
- DRUG mycophenolate mofetil [CellCept]
- DRUG Calcineurin inhibitors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 305 participants |
| Start Date | 2003-08 |
| Est. Completion | 2009-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00121810
The ClinicalTrials.gov registry entry for NCT00121810 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 305 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 4 interventions - of which Sirolimus is the first listed.
NCT00121810 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00121810 about?
NCT00121810 is a clinical study titled "Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients". This 2-arm study recruited kidney transplant patients who were receiving standard care of calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily) and corticosteroids. They were either randomized to continue this regimen, or CNI therapy was discontinued and replace...
What is the current status of trial NCT00121810?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 305 participants. The study started on 2003-08. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00121810?
The interventions under investigation include: Sirolimus (DRUG), Corticosteroids (DRUG), mycophenolate mofetil [CellCept] (DRUG), Calcineurin inhibitors (DRUG).
Who is sponsoring clinical trial NCT00121810?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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