evaluating aranesp® for the treatment of anemia in african-american subjects with chronic renal failure (crf) receiving hemodialysis

Conditions: Chronic Renal Failure; Anemia

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.


Eligibility 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)

Keywords: chronic renal failure (crf) anemia