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NCT00422513 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 260
- Enrollment target
NCT00422513: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00422513 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 260 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00422513, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 260 participants
- Enrollment target
Study Summary
This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Primary Outcome
Efficacy and pharmacoeconomics analyses were not performed.
Interventions
- DRUG Epoetin alfa
- DRUG methoxy polyethylene glycol-epoetin beta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2007-03 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
Why NCT00422513 stopped before completion
NCT00422513 is an interventional study that assigns participants to a tested intervention. The registered 260 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 (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Epoetin alfa is the first listed.
NCT00422513 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00422513 about?
NCT00422513 is a clinical study titled "A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.". This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenou...
What is the current status of trial NCT00422513?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 260 participants. The study started on 2007-03. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00422513?
The interventions under investigation include: Epoetin alfa (DRUG), methoxy polyethylene glycol-epoetin beta (DRUG).
Who is sponsoring clinical trial NCT00422513?
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 NCT00422513's enrollment target sits among peer trials
260 1230th of 2000 higher than 767 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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