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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00111995
First received: May 27, 2005
Last updated: August 7, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Chronic Renal Failure
Anemia
Drug: Aranesp®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

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

Estimated Enrollment: 400
Study Start Date: May 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111995

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00111995     History of Changes
Other Study ID Numbers: 20010125
Study First Received: May 27, 2005
Last Updated: August 7, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Chronic Renal Failure (CRF)
Anemia

Additional relevant MeSH terms:
Anemia
Kidney Failure, Chronic
Renal Insufficiency
Hematologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014