Evaluating Aranesp® for the Treatment of Anemia in African-American Subjects With Chronic Renal Failure (CRF) Receiving Hemodialysis
Study Details
Study Description
Brief Summary
This study is designed to evaluate the hemoglobin response to Aranesp® (darbepoetin alfa) in black subjects (African-Americans) with chronic renal failure (CRF) receiving hemodialysis and to examine the safety profile.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Study Design
Outcome Measures
Primary Outcome Measures
- Mean hemoglobin level during the evaluation period []
Secondary Outcome Measures
- The nature, frequency, severity, relationship to treatment, and outcome of adverse events with specific attention to hypertensive events []
Eligibility Criteria
Criteria
Inclusion Criteria: - Diagnosis of CRF and 3 times weekly prescribed hemodialysis treatments for at least 8 weeks before signing informed consent - No planned change in dialysis modality or schedule - Black (as indicated on the Chronic Medical Evidence Disease Report, CMMS Form 2728) - Hemoglobin 9.5 to 12.5 g/dL on 2 consecutive occasions during the screening period (1 week + 2 days apart) and baseline hemoglobin level of 9.5 - 12.5 g/dL (defined as the mean of all measurements taken during the screening and baseline periods) - Transferrin saturation greater than or equal to 20% but less than or equal to 50% - Stable rHuEPO therapy given 3 times per week by intravenous (IV) route of administration for 6 weeks before randomization (stable is defined as less than or equal to 25% change in prescribed dose over 6 weeks, same route of administration, and no more than 1 missed or withheld dose during each of the two 3-week periods before randomization) Exclusion Criteria: - Scheduled for a living-related or living non-related donor transplant - rHuEPO dose greater than 40,000 units weekly - Uncontrolled hypertension (postdialysis diastolic blood pressure greater than 105 mmHg and/or systolic blood pressure greater than 180 mmHg on more than 1 occasion as noted in the collected blood pressure measurements during the screening/baseline period) - Congestive heart failure (New York Heart Association [NYHA] Class III or IV) - Major surgery (excluding vascular access surgery) within 8 weeks before signing informed consent and during screening/baseline - Clinical evidence of active inflammatory disease requiring cyclophosphamide, azathioprine, prednisone or other immunosuppressive therapy within 8 weeks before signing the informed consent and during screening/baseline - Currently (at the signing of the informed consent) receiving antibiotics for a systemic infection and during screening/baseline - Known positivity for HIV antibody or hepatitis B surface antigen - Grand mal seizures within the last year - Clinical evidence of current malignancy (other than non-melanomatous skin malignancy), and/or receiving chemotherapy, and/or radiation therapy for malignancies within 8 weeks of signing the informed consent and during screening/baseline - Active systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic anemia) within 8 weeks of signing the informed consent and during screening/baseline - Clinical evidence of severe hyperparathyroidism (parathyroid hormone [PTH] level greater than 1500 pg/mL or biopsy-proven bone marrow fibrosis) at last measurement - ALT or AST greater than 2x the upper limit of the normal range - Red blood cell transfusions within 8 weeks before signing the informed consent and during screening/baseline - Known hypersensitivity to human serum albumin (HSA)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- AmgenTrials clinical trials website
- Notice regarding posted summaries of trial results
- To access clinical trial results information click on this link
- FDA-approved Drug Labeling
Publications
None provided.- 20010125