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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00699348 |
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the ESA dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10-12g/dL. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Condition | Intervention | Phase |
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Anemia |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia |
Estimated Enrollment: | 400 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | January 2010 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
i.v. every month (starting dose based on previous ESA therapy).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML21438, 2007-005799-15 |
Study First Received: | June 17, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00699348 |
Health Authority: | Italy: Ministry of Health |
Epoetin Alfa Hematologic Diseases Anemia |