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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00116701 |
Treatment period 1:To demonstrate that switching HD subjects with a baseline haemoglobin (Hb) ≥ 10 g/dL and ≤ 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV darbepoetin alfa results in a mean Hb > 11 g/dL. Treatment Period 2:To demonstrate that switching subjects with a Hb > 11 g/dL and ≤ 13 g/dL from once weekly IV darbepoetin alfa to once every 2 weeks (Q2W) maintains the mean Hb at > 11 g/dL.
Condition | Intervention | Phase |
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Kidney Disease |
Drug: Aranesp® |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Study to Evaluate the Efficacy of Converting From Intravenous or Subcutaneous rHuEPO to Intravenous Darbepoetin Alfa (Aranesp®) in Subjects With Chronic Kidney Disease Receiving Haemodialysis |
Estimated Enrollment: | 200 |
Study Start Date: | May 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: -at least 18 years old - Diagnosis of chronic kidney disease (CKD) and receiving dialysis for at least 3 months prior to screening - Baseline Hb level greater than or equal to 10.0 g/dL and less than or equal to 13.0 g/dL - Adequate iron stores (defined as serum ferritin greater than or equal to 100 µg/L or transferrin saturation [TSAT] greater than or equal to 20%) - Stable IV (epoetin alfa or beta) or SC rHuEPO (epoetin beta) therapy 2 or 3 times per week for at least 8 weeks before screening (stable is defined as less than 25% change in weekly dose and no change in frequency or route) - All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial. Exclusion Criteria: - Received SC epoetin alfa in the 12 months before screening - Uncontrolled hypertension (diastolic blood pressure greater than 100 mmHg or systolic blood pressure greater than 180 mmHg on 2 separate occasions during screening) - Prior history (within 12 weeks before enrolment) of cardiovascular events including:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20040218 |
Study First Received: | June 30, 2005 |
Last Updated: | May 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00116701 History of Changes |
Health Authority: | Hungary: National Institute of Pharmacy |
Chronic Kidney Disease (CKD) Haemoglobin (Hb) Erthropoetin (EPO) End Stage Renal Disease (ESRD) Recombinant Human Erthropoetic (rHuEPO) |
Anaemia Darbepoetin Alfa, Aranesp® Haemodialysis Clinical Trial |
Renal Insufficiency Urologic Diseases Hematinics Renal Insufficiency, Chronic Darbepoetin alfa |
Anemia Kidney Failure, Chronic Kidney Diseases 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 |