Subcutaneous (SC) Darbepoetin Alfa in Subjects With Symptomatic Congestive Heart Failure (CHF) & Anemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether weight-based or fixed starting doses result in comparable hemoglobin increases and treatment effects in patients with heart failure and anemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Darbepoetin alfa

Criteria

Inclusion Criteria: - Symptomatic CHF for at least 3 months - Reduced left ventricular ejection fraction - Stable heart failure medication - Hemoglobin concentration between 9.0 and 12.5 g/dL Exclusion Criteria: - Hypertension - Unstable angina pectoris or recent myocardial infarction - Likely to receive cardiac transplant - Major organ transplant (e.g., lung, liver, heart) or in renal replacement therapy (e.g., dialysis) - Recent or current treatment for malignancy - Systemic hematologic disease - Anemia due to acute or chronic bleeding - Recent Epogen® or darbepoetin alfa therapy - Recent blood transfusion