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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: June 30, 2005
Last updated: October 15, 2009
Last verified: October 2009
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.

Condition Intervention Phase
Congestive Heart Failure
Drug: darbepoetin alfa
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Pharmacokinetic profiling of Aranesp® in HF pts

Secondary Outcome Measures:
  • Pharmacodynamic responses (hgb) following Aranesp® administration in HF patients

Study Start Date: June 2002
Estimated Study Completion Date: July 2004

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00117247

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00117247     History of Changes
Other Study ID Numbers: 20010198 
Study First Received: June 30, 2005
Last Updated: October 15, 2009
Health Authority: European Union: European Medicines Agency

Keywords provided by Amgen:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Hematologic Diseases
Darbepoetin alfa
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 10, 2016