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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00077623 |
This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. 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 alfa or beta |
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 Maintenance Subcutaneous Mircera on Hemoglobin Levels in Dialysis Patients With Chronic Kidney Disease |
Enrollment: | 572 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
30, 50 or 90 micrograms sc (starting dose) every 2 weeks
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2: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
30, 50 or 90 micrograms sc (starting dose) every 4 weeks
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3: Active Comparator |
Drug: epoetin alfa or beta
iv 3 times weekly, 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: | BA16740 |
Study First Received: | February 10, 2004 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00077623 |
Health Authority: | United States: Food and Drug Administration |
Epoetin Alfa Hematologic Diseases Renal Insufficiency, Chronic |
Anemia Kidney Failure, Chronic Kidney Diseases |
Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |