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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 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 111 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00454246
The ClinicalTrials.gov registry entry for NCT00454246 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 111 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 3 interventions - of which darbepoetin alfa is the first listed.
NCT00454246 reports 0 study locations.
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.
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