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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 June 2013 |
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Main ID: |
NCT00048048 |
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Date of registration:
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24/10/2002 |
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Primary sponsor: |
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Public title:
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A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.
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Scientific title:
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A Randomized, Open-label Study of the Effect of Different Dosing Intervals of Subcutaneous Mircera on Hemoglobin Level/Correction in Patients With Chronic Renal Anemia |
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Date of first enrolment:
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March 2002 |
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Target sample size:
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65 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00048048 |
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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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Canada
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France
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Mexico
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Poland
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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;
- not receiving renal replacement therapy.
Exclusion Criteria:
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of any investigational drug within 30 days preceding the screening
visit and during the run-in 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: methoxy polyethylene glycol-epoetin beta [Mircera]
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Primary Outcome(s)
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Hemoglobin levels\n
[Time Frame: Throughout study]
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Secondary Outcome(s)
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Hematocrit, reticulocyte count. Vital signs, adverse events, laboratory values\n\n
[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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