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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: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00121810 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 305 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary efficacy endpoint was mean percent change in renal function from baseline to 12 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate. percent change= \[(Glomerular Filtration Rate at Month 12-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline\]\*100 percent.
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 |
What the finished NCT00121810 record still lists
NCT00121810 is an interventional study that assigns participants to a tested intervention. The registered 305 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 4 interventions - of which Sirolimus is the first listed.
NCT00121810 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00121810's enrollment target sits among peer trials
305 264th of 2000 higher than 1,737 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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