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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 June 2013 |
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Main ID: |
NCT00077623 |
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Date of registration:
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10/02/2004 |
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Primary sponsor: |
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Public title:
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A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.
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Scientific title:
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A Randomized, Open-label Study of the Effect of Maintenance Subcutaneous Mircera on Hemoglobin Levels in Dialysis Patients With Chronic Kidney Disease |
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Date of first enrolment:
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March 2004 |
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Target sample size:
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572 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00077623 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Belgium
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Brazil
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Czech Republic
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Denmark
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Finland
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France
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Germany
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Hungary
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Italy
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Mexico
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New Zealand
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Panama
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Poland
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Puerto Rico
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South Africa
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Spain
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Sweden
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Taiwan
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Thailand
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adult patients >=18 years of age;
- chronic renal anemia;
- on dialysis therapy for at least 12 weeks before screening;
- receiving sc epoetin for at least 8 weeks before screening.
Exclusion Criteria:
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of another investigational drug within 4 weeks before screening, or
during the study period.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anemia
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Intervention(s)
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Drug: epoetin alfa or beta
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Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
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Primary Outcome(s)
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Change in hemoglobin concentration
[Time Frame: Weeks 1-36]
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Secondary Outcome(s)
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AEs, laboratory parameters, vital signs
[Time Frame: Throughout study]
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Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration\n
[Time Frame: Weeks 29-36]
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RBC transfusions
[Time Frame: Weeks 1-36]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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