A Study of Subcutaneous Mircera For The Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis - NCT00642967-CHALON SUR SAONE - 0029 (Clinical Trial 211115)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy211115.aspx
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CHALON SUR SAONE |
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Country:
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France |
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| Conditions: |
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Anemia |
| Purpose: |
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This single arm study will assess the efficacy and safety of monthly administration of
subcutaneous Mircera when administered for the maintenance of hemoglobin levels in patients
with chronic renal anemia, not on dialysis.
Patients currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will
receive monthly subcutaneous injections of Mircera, with the starting dose (120 or 200
micrograms) calculated from the last weekly dose of ESA previously administered. The
anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
individuals.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- adult patients, >=18 years of age;
- chronic kidney disease stage 3 or 4, with chronic renal anemia, not requiring
dialysis;
- continuous stable subcutaneous maintenance ESA therapy during previous month.
Exclusion Criteria:
- transfusion of red blood cells during previous 2 months;
- significant acute or chronic bleeding;
- poorly controlled hypertension. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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October 9, 2009 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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