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

Phase 2

Completed

• Conditions: Congestive Heart Failure; Anemia

• Registration Number: NCT00086086
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2004-06-23
• Study First Submitted QC: 2004-06-23
• Study First Posted: 2004-06-24
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-07
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of rise of hemoglobin concentration

Secondary Outcome Measures

Name	Time	Method
Change in left ventricular ejection fraction
Change in 6-minute walk distance
NYHA classification
Patient-reported outcomes