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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aranesp® | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment period 1: Mean haemoglobin during the evaluation period (weeks 21-24) | ||
| Treatment period 2: Mean haemoglobin during evaluation period 2 (weeks 45-48) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment period 2: Change in Hb between Evaluation Period 1 and Evaluation Period 2 | ||
| Treatment period 2: The proportion of subjects with a change in Hb between Evaluation Period 1 and Evaluation Period 2 within the inclusive range -1.0 to +1.5 g/dL |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
| FDA-approved Drug Labeling | View source |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| Treatment period 2: The proportion of subjects with a mean Hb > 11.0 g/dL during Evaluation Period 2 |
| Treatment period 2: Dose and frequency of darbepoetin alfa administration over the treatment period |
| Treatment period 1:The proportion of subjects with a mean Hb > 11.0 g/dL during the evaluation period |
| Treatment period 1: Change in Hb between screening/baseline and the evaluation period |
| Treatment period 1: Dose and frequency of darbepoetin alfa administration over the treatment period |
| D052801 | Male Urogenital Diseases |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002241 |
| Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |