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| Sponsor: | Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00124098 |
Purpose
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 |
Eligibility| 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:
Contacts and Locations
More Information
| 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 History of Changes |
| 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 Hematinics Renal Insufficiency, Chronic Therapeutic Uses Hematologic Agents |
Darbepoetin alfa Kidney Failure, Chronic Kidney Diseases Pharmacologic Actions Kidney Failure |