A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis. - NCT00442702-26506 (Clinical Trial 164402)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy164402.aspx
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| City: |
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Morgantown |
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State:
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WV |
| Zip Code: |
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26506 |
| Conditions: |
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Anemia |
| Purpose: |
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This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the
treatment of anemia in patients with chronic kidney disease who are not on dialysis and who
are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized
either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly
subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the
weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. 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, not requiring dialysis;
- receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and
during screening/baseline period.
Exclusion Criteria:
- overt gastrointestinal bleeding within 8 weeks before screening, or during
screening/baseline period;
- transfusion of red blood cells within 8 weeks before screening, or during
screening/baseline period;
- active malignant disease;
- previous treatment with Mircera. |
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| Study is available at: |
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Morgantown, WV 26506
United States
Primary Contact:
Please reference Study ID Number: BH20051
Email: genentechclinicaltrials@druginfo.com
Phone: 888-662-6728 (U.S. Only) |
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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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March 15, 2010 |
Modifications to
this listing: |
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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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