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NCT00442416 · ClinicalTrials.gov registry record · Phase 3
A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
NCT00442416: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00442416 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 80 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00442416, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
Study Summary
This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomized either to receive monthly sc injections of Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 380 individuals.
Primary Outcome
Mean change in Hb concentration from Baseline (Day \[D\] 0) to average during the evaluation period (Month 7 to 9) is reported.
Interventions
- DRUG Epoetin alfa
- DRUG methoxy polyethylene glycol-epoetin beta [Mircera]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2007-02 |
| Est. Completion | 2008-01 |
| Phase | Phase 3 |
Why NCT00442416 stopped before completion
NCT00442416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Epoetin alfa is the first listed.
NCT00442416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00442416 about?
NCT00442416 is a clinical study titled "A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.". This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patien...
What is the current status of trial NCT00442416?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2007-02. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00442416?
The interventions under investigation include: Epoetin alfa (DRUG), methoxy polyethylene glycol-epoetin beta [Mircera] (DRUG).
Who is sponsoring clinical trial NCT00442416?
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 NCT00442416's enrollment target sits among peer trials
80 1755th of 2000 higher than 233 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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