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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00680563 |
This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, 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: | An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Once-Monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA. |
Estimated Enrollment: | 280 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2010 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
sc every month (starting dose 1.2 micrograms/kg)
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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:
Contact: Please reference Study ID Number: ML21467 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML21467 |
Study First Received: | May 16, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00680563 |
Health Authority: | Brazil: Ministry of Health |
Epoetin Alfa Hematologic Diseases Anemia |