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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00377637 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 370 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Treatment response was adjudicated by a blinded clinical endpoints committee (CEC) and defined as: a) Decrease in proteinuria, defined as a decrease in the urine protein to creatinine ratio (UPCr) to \<3 in subjects with baseline proteinuria ≥3 UPCr or a decrease in the UPCr by ≥50% in subjects with proteinuria \<3 UPCr at Baseline, and b) Stabilization of serum creatinine or improvement. UPCr were derived from the 24 hour urine collection. Patients who did not show a treatment response at Week
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 |
What the finished NCT00377637 record still lists
NCT00377637 is an interventional study that assigns participants to a tested intervention. The registered 370 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00377637 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00377637's enrollment target sits among peer trials
370 993rd of 2000 higher than 1,006 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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