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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: |
NCT00576628 |
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Date of registration:
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18/12/2007 |
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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 Pre-Dialysis Patients.
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Scientific title:
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An Open Label Study to Assess the Effect on Anemia Correction, Maintenance of Haemoglobin Levels, Safety and Tolerability of Monthly Administration of Subcutaneous Mircera in Pre-dialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA. |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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126 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00576628 |
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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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Russian Federation
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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, with no need for dialysis expected in next 3 months;
- adequate iron status.
Exclusion Criteria:
- previous epoetin therapy within 12 weeks prior to treatment;
- transfusion of red blood cells during 2 months prior to screening;
- significant acute or chronic bleeding such as overt gastrointestinal bleeding;
- hemolysis;
- folic acid and vitamin B 12 deficiency.
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 [Mircera]
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Primary Outcome(s)
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Change in Hb concentration between screening and evaluation period
[Time Frame: Weeks 29-36]
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Secondary Outcome(s)
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AEs, laboratory parameters.
[Time Frame: Throughout study]
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Mean time spent in target Hb range; mean number of months/subject requiring any dose adjustment; RBC transfusions.
[Time Frame: Throughout study]
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Percentage of patients maintaining average Hb concentration of 11.0-13.0g/dL throughout evaluation period.
[Time Frame: Weeks 29-36]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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