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NCT00118742 · ClinicalTrials.gov registry record · Phase 4
Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 293
- Enrollment target
NCT00118742: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00118742 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 293 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00118742, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 293 participants
- Enrollment target
Study Summary
This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1.5 g BID + sirolimus. The anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500 individuals.
Primary Outcome
Mean percent change from baseline in estimated glomerular filtration rate (GFR) calculated by modification of diet in renal disease (MDRD)-6 variable equation at 12 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.
Interventions
- DRUG Sirolimus
- DRUG Tacrolimus
- DRUG Cyclosporine
- DRUG mycophenolate mofetil [CellCept]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 293 participants |
| Start Date | 2005-08 |
| Est. Completion | 2008-12 |
| Phase | Phase 4 |
What the finished NCT00118742 record still lists
NCT00118742 is an interventional study that assigns participants to a tested intervention. The registered 293 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 (43% lower).
The record links to 0 conditions, and to 4 interventions - of which Sirolimus is the first listed.
NCT00118742 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00118742 about?
NCT00118742 is a clinical study titled "Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant". This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g twice daily (BID) + tacrolimus + cyclospor...
What is the current status of trial NCT00118742?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 293 participants. The study started on 2005-08. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00118742?
The interventions under investigation include: Sirolimus (DRUG), Tacrolimus (DRUG), Cyclosporine (DRUG), mycophenolate mofetil [CellCept] (DRUG).
Who is sponsoring clinical trial NCT00118742?
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 NCT00118742's enrollment target sits among peer trials
293 296th of 2000 higher than 1,705 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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