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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00517413 |
This single arm study will assess the efficacy and safety of Mircera when administered once monthly, subcutaneously or intravenously, for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will receive monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Condition | Intervention | Phase |
---|---|---|
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 to Assess the Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Monthly Administration of Intravenous or Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia |
Estimated Enrollment: | 200 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | April 2010 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms sc or iv monthly, starting dose
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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: ML20881 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
Argentina | |
Active, not recruiting | |
BUENOS AIRES, Argentina, 1155 | |
Active, not recruiting | |
BUENOS AIRES, Argentina, 1663 | |
Active, not recruiting | |
SANTA FE, Argentina, 3000 | |
Active, not recruiting | |
BUENOS AIRES, Argentina, 1437 | |
Recruiting | |
CÓRDOBA, Argentina, 5000 | |
Recruiting | |
BUENOS AIRES, Argentina, 1824 | |
Brazil | |
Recruiting | |
CURITIBA, Brazil, 80050-350 | |
Recruiting | |
SAO PAULO, Brazil, 05624-000 | |
Recruiting | |
ARACAJÚ, Brazil, 49055-210 | |
Recruiting | |
FORTALEZA, Brazil, 60430-370 | |
Chile | |
Active, not recruiting | |
SANTIAGO, Chile, 056 | |
Colombia | |
Terminated | |
BOGOTA, Colombia, 0 | |
Active, not recruiting | |
BOGOTÁ, Colombia | |
Ecuador | |
Active, not recruiting | |
QUITO, Ecuador, 2569 | |
Mexico | |
Active, not recruiting | |
CUERNAVACA, Mexico, 62448 | |
Active, not recruiting | |
MEXICO CITY, Mexico, 14000 | |
Active, not recruiting | |
MEXICO CITY, Mexico, 14050 | |
Active, not recruiting | |
MEXICO CITY, Mexico, 03900 | |
Active, not recruiting | |
MONTERREY, Mexico, 64710 | |
Active, not recruiting | |
MEXICO CITY, Mexico, 11520 | |
Peru | |
Active, not recruiting | |
CALLAO, Peru, C 01 | |
Active, not recruiting | |
CALLAO, Peru, C01 | |
Active, not recruiting | |
LIMA, Peru, L13 | |
Uruguay | |
Active, not recruiting | |
MONTEVIDEO, Uruguay, 11600 | |
Recruiting | |
MONTEVIDEO, Uruguay, 11800 | |
Venezuela | |
Active, not recruiting | |
MARACAIBO, Venezuela, 4002 | |
Active, not recruiting | |
CARACAS, Venezuela, 1062 | |
Active, not recruiting | |
CARACAS, Venezuela, 1060 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML20881 |
Study First Received: | August 16, 2007 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00517413 History of Changes |
Health Authority: | Ecuador: Ministry of Health |
Epoetin Alfa Hematologic Diseases Anemia |
Hematologic Diseases Anemia |