Evaluating Aranesp® for the Treatment of Anemia in African-American Subjects With Chronic Renal Failure (CRF) Receiving Hemodialysis

Overview

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.

Full Title of Study: “A Randomized, Double-Blind Study Comparing Aranesp® (Darbepoetin Alfa) and Recombinant Human Erythropoietin (rHuEPO) in the Treatment of Anemia in African-American Subjects With Chronic Renal Failure (CRF) Receiving Hemodialysis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: Double

Interventions

  • Drug: Aranesp®

Clinical Trial Outcome Measures

Primary Measures

  • Mean hemoglobin level during the evaluation period

Secondary Measures

  • The nature, frequency, severity, relationship to treatment, and outcome of adverse events with specific attention to hypertensive events

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Amgen
  • Provider of Information About this Clinical Study
    • Global Development Leader, Amgen Inc.
  • Overall Official(s)
    • MD, Study Director, Amgen

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