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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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17 October 2012 |
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Main ID: |
NCT00560547 |
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Date of registration:
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16/11/2007 |
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Primary sponsor: |
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Public title:
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A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.
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Scientific title:
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An Open Label Study to Assess the Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Monthly Administration of Mircera in Hemodialysis Patients With Chronic Renal Anemia. |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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200 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT00560547 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Denmark
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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;
- regular long-term hemodialysis therapy with the same mode of dialysis for >=3 months;
- continuous iv or sc maintenance ESA treatment during previous 2 months.
Exclusion Criteria:
- transfusion of red blood cells during previous 2 months;
- significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
- active malignant disease (except non-melanoma skin cancer).
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: methoxy polyethylene glycol-epoetin beta
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Primary Outcome(s)
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Percentage of patients maintaining average Hb concentration within target range during evaluation period
[Time Frame: Weeks 17-24]
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Secondary Outcome(s)
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AEs, laboratory parameters, vital signs
[Time Frame: Throughout study]
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Change in Hb concentration between reference and evaluation period; mean time spent in, and percentage of patients maintaining Hb within target range
[Time Frame: Weeks 17-24]
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Dose adjustments; RBC transfusions
[Time Frame: Throughout study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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