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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111995
• Other study ID #: 20010125
• Status: Completed
• Phase: Phase 4
• First received: May 27, 2005
• Last updated: August 7, 2008
• Start date: May 2002

Study information

• Verified date: August 2008
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Aranesp®

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean hemoglobin level during the evaluation period
Secondary	The nature, frequency, severity, relationship to treatment, and outcome of adverse events with specific attention to hypertensive events

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling