Completed

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

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What is being tested

Data Collection

Who is being recruted

Anemia+2

+ Cardiovascular Diseases

+ Heart Diseases

Over 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2003
See protocol details

Summary

Principal SponsorAmgen
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleA 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 
NCT00086086
Principal SponsorAmgen
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnemiaCardiovascular DiseasesHeart DiseasesHeart FailureHematologic Diseases

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
CompletedNo study centers