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NCT00454246 · ClinicalTrials.gov registry record · Phase 3
A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 111
- Enrollment target
NCT00454246: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00454246 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 111 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00454246, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 111 participants
- Enrollment target
Study Summary
This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. Patients will be randomized either to receive Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc) Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a starting dose based on their previous (sc) dose, and those in the control group will receive weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.
Primary Outcome
Efficacy analyses were not performed.
Interventions
- DRUG darbepoetin alfa
- DRUG epoetin alfa
- DRUG methoxy polyethylene glycol-epoetin beta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2007-04 |
| Est. Completion | 2008-02 |
| Phase | Phase 3 |
Why NCT00454246 stopped before completion
NCT00454246 is an interventional study that assigns participants to a tested intervention. The registered 111 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 (86% lower).
The record links to 0 conditions, and to 3 interventions - of which darbepoetin alfa is the first listed.
NCT00454246 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00454246 about?
NCT00454246 is a clinical study titled "A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.". This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through...
What is the current status of trial NCT00454246?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 111 participants. The study started on 2007-04. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00454246?
The interventions under investigation include: darbepoetin alfa (DRUG), epoetin alfa (DRUG), methoxy polyethylene glycol-epoetin beta (DRUG).
Who is sponsoring clinical trial NCT00454246?
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 NCT00454246's enrollment target sits among peer trials
111 1655th of 2000 higher than 344 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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