Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 260 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00422513
The ClinicalTrials.gov registry entry for NCT00422513 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 260 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 2 interventions - of which Epoetin alfa is the first listed.
NCT00422513 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.