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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00124098 |
The purpose of this study is to assess if Aranesp® administered once every 4 weeks to chronic kidney disease subjects is safe and efficacious in maintaining haemoglobin levels greater than or equal to 100 g/L.
Condition | Intervention | Phase |
---|---|---|
Kidney Disease |
Drug: Aranesp® (darbepoetin alfa) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Study of Aranesp® (Darbepoetin Alfa) Administration Once Every Four Weeks in Anaemic Chronic Kidney Disease (CKD) Subjects |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Creatinine clearance greater than 15 and less than 40 mL/min as estimated by the Cockroft-Gault equation:
A stable dose is defined as less than or equal to 25% change in Aranesp® dose over the 6-week period immediately prior to enrollment and with no more than
1 missed dose over this period
Exclusion Criteria:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20030112 |
Study First Received: | June 30, 2005 |
Last Updated: | June 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00124098 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Chronic Kidney Disease (CKD) anemia, clinical trial darbepoetin alfa Aranesp® Amgen |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Darbepoetin alfa |
Anemia Kidney Failure, Chronic Kidney Diseases Kidney Failure |
Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |