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

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ClinicalTrials.gov Identifier: NCT00086086
Recruitment Status : Completed
First Posted : June 24, 2004
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Anemia Drug: Darbepoetin Alfa Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Effects of Treatment With 2 Regimens of Subcutaneous Darbepoetin Alfa (Weight-based Dosing and Fixed Dosing) on Hemoglobin Concentration Response in Subjects With Symptomatic CHF and Anaemia
Study Start Date : August 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Rate of rise of hemoglobin concentration

Secondary Outcome Measures :
  1. Change in left ventricular ejection fraction
  2. Change in 6-minute walk distance
  3. NYHA classification
  4. Patient-reported outcomes

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086086


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00086086     History of Changes
Other Study ID Numbers: 20020171
First Posted: June 24, 2004    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017

Keywords provided by Amgen:
Symptomatic Congestive Heart Failure
CHF
Anaemia
Anemia

Additional relevant MeSH terms:
Heart Failure
Anemia
Heart Diseases
Cardiovascular Diseases
Hematologic Diseases
Darbepoetin alfa
Hematinics