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NCT00086086 Clinical Trial

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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00086086
Other study ID # 20020171
Secondary ID
Status Completed
Phase Phase 2
First received June 23, 2004
Last updated February 7, 2017
Start date August 2003

Study information
Verified date February 2017
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Darbepoetin Alfa

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

References & Publications (1)

van Veldhuisen DJ, Dickstein K, Cohen-Solal A, Lok DJ, Wasserman SM, Baker N, Rosser D, Cleland JG, Ponikowski P. Randomized, double-blind, placebo-controlled study to evaluate the effect of two dosing regimens of darbepoetin alfa in patients with heart failure and anaemia. Eur Heart J. 2007 Sep;28(18):2208-16. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of rise of hemoglobin concentration
Secondary Change in left ventricular ejection fraction
Secondary Change in 6-minute walk distance
Secondary NYHA classification
Secondary Patient-reported outcomes
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