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NCT00377637 · ClinicalTrials.gov registry record · Phase 3
A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 370
- Enrollment target
NCT00377637 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 370 participants.
The verdict
NCT00377637, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 370 participants
- Enrollment target
Study Summary
This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of MMF compared to azathioprine in maintaining remission and renal function. Patients were randomized to receive either MMF (1.5 g twice daily \[bid\]) or cyclophosphamide (0.5-1.0 g/m\^2 in monthly pulses) in the induction phase. Those patients meeting criteria for response were re-randomized for entry into the maintenance phase, to receive either MMF (1 g bid) or azathioprine (2 mg/kg/day).
Interventions
- DRUG Cyclophosphamide
- DRUG Azathioprine
- DRUG Mycophenolate mofetil (MMF)
- DRUG Placebo to Azathioprine
- DRUG Placebo to Mycophenolate mofetil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2005-07 |
| Est. Completion | 2010-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00377637
The ClinicalTrials.gov registry entry for NCT00377637 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 370 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 5 interventions - of which Cyclophosphamide is the first listed.
NCT00377637 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00377637 about?
NCT00377637 is a clinical study titled "A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.". This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of MMF compared to azathioprine in maintaining remission and renal function. Patients were randomized to re...
What is the current status of trial NCT00377637?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 370 participants. The study started on 2005-07. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00377637?
The interventions under investigation include: Cyclophosphamide (DRUG), Azathioprine (DRUG), Mycophenolate mofetil (MMF) (DRUG), Placebo to Azathioprine (DRUG), Placebo to Mycophenolate mofetil (DRUG).
Who is sponsoring clinical trial NCT00377637?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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