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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00117247

Enrollment

Unknown

Registered

2005-07-06

Start date

2002-06-30

Completion date

2004-07-31

Last updated

2009-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Congestive Heart Failure

Keywords

Heart Failure

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.

Interventions

DRUGdarbepoetin alfa

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic profiling of Aranesp® in HF pts	—

Secondary

Measure	Time frame
Pharmacodynamic responses (hgb) following Aranesp® administration in HF patients	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026