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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00368901 |
To assess the effect of Aranesp on the hemoglobin (Hgb) of CRI subjects who are recombinant human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy.
Condition | Intervention | Phase |
---|---|---|
Chronic Kidney Disease Chronic Renal Insufficiency Kidney Disease Pre-Dialysis Pre-ESRD |
Drug: darbepoetin alfa |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Study Using Once Every Other Week Subcutaneous Administration of Aranesp™ (Darbepoetin Alfa) and Iron Guided Algorithms to Treat Subjects With Anemia of Chronic Renal Insufficiency (CRI) |
Estimated Enrollment: | 2000 |
Study Start Date: | January 2002 |
Estimated Study Completion Date: | May 2004 |
To assess the effect of Aranesp_ on the hemoglobin (Hgb) of CRI subjects who are recombinant human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy. To assess the association between subject self-reported health-related quality of life (HRQoL) as it relates to Hgb concentration and glomerular filtration rate (GFR) in subjects who were rHuEPO-naïve prior to study enrollment. To characterize the health-related resource utilization of subjects with CRI. To characterize the subject satisfaction with Aranesp_ compared to previous rHuEPO therapy.
To characterize iron treatment in subjects with CRI. To assess the safety profile of Aranesp_ therapy in subjects with CRI
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20010215 |
Study First Received: | August 24, 2006 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00368901 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Aranesp Anemia Kidney Disease |
Hemoglobin darbepoetin alfa QoL |
Renal Insufficiency Urologic Diseases Hematinics Renal Insufficiency, Chronic Darbepoetin alfa |
Anemia Kidney Failure, Chronic Kidney Diseases Iron Kidney Failure |
Renal Insufficiency Urologic Diseases Hematinics Renal Insufficiency, Chronic Therapeutic Uses Hematologic Agents |
Darbepoetin alfa Kidney Failure, Chronic Kidney Diseases Pharmacologic Actions Kidney Failure |