A Study of Repeat-Dose Subcutaneous Darbepoetin Alfa in Subjects With Congestive Heart Failure and Anemia, and a Single Dose in Healthy Age- and Sex-Matched Control Subjects

Phase 1

Completed

• Conditions: Anemia; Congestive Heart Failure

• Registration Number: NCT00117247
• Lead Sponsor: Amgen

Brief Summary

The purpose of this study is to evaluate the single dose pharmacokinetics (PK) of subcutaneous (SC) darbepoetin alfa in subjects with congestive heart failure (CHF) and anemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study Completion: 2004-07
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-06
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-15
• Last Update Posted: 2009-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Symptomatic CHF despite optimized therapy for at least the previous 3 months (treatment included a diuretic, angiotensin converting enzyme [ACE] inhibitor, and/or an A2 antagonist, unless not tolerated) - Hemoglobin greater than or equal to 12.5 g/dL at the time of screening

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic profiling of Aranesp® in HF pts

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic responses (hgb) following Aranesp® administration in HF patients