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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00077597 |
This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently 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.
Condition | Intervention | Phase |
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Anemia |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Drug: epoetin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease |
Enrollment: | 182 |
Study Completion Date: | June 2006 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
0.4 micrograms/kg iv (starting dose) once every 2 weeks
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2: Active Comparator |
Drug: epoetin
3 times a week iv, as prescribed.
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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: | BA16736 |
Study First Received: | February 10, 2004 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00077597 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Epoetin Alfa Hematologic Diseases Renal Insufficiency, Chronic |
Anemia Kidney Failure, Chronic Kidney Diseases |
Hematologic Diseases Anemia |