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NCT00081471 · ClinicalTrials.gov registry record · Phase 3
A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis
A Phase 3 study of Anemia, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 324
- Enrollment target
- 20
- Study locations
NCT00081471 is a Phase 3 study of Anemia that has completed, run by Hoffmann-La Roche. The registered enrollment target is 324 participants, below the 423-participant average among 72 other Anemia trials with a reported enrollment target (23% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT00081471, a Phase 3 study of Anemia, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 324 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Conditions Studied
Interventions
- DRUG darbepoetin alfa
- DRUG methoxy polyethylene glycol-epoetin beta [Mircera]
Study Locations (20)
California
- - Los Angeles
- - Mather
- - Stanford
Texas
- - Austin
- - Dallas
- - Houston
Florida
- - Bay Pines
- - Ocala
Massachusetts
- - Boston
- - Boston
Connecticut
- - Stamford
Louisiana
- - Shreveport
Michigan
- - Detroit
New York
- - Flushing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 324 participants |
| Start Date | 2004-06 |
| Est. Completion | 2006-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00081471
The ClinicalTrials.gov registry entry for NCT00081471 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 324 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 423-participant average among 72 other Anemia trials with a reported enrollment target (23% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Anemia appearing as the primary indexed condition, and to 2 interventions - of which darbepoetin alfa is the first listed.
NCT00081471 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Texas, Florida.
Frequently Asked Questions
What is clinical trial NCT00081471 about?
NCT00081471 is a clinical study titled "A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis". This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target...
What is the current status of trial NCT00081471?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 324 participants. The study started on 2004-06. Estimated completion is 2006-07.
What conditions does trial NCT00081471 study?
This clinical trial studies the following conditions: Anemia.
What interventions are being tested in trial NCT00081471?
The interventions under investigation include: darbepoetin alfa (DRUG), methoxy polyethylene glycol-epoetin beta [Mircera] (DRUG).
Who is sponsoring clinical trial NCT00081471?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00081471 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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