NCT00119587

Brief Summary

The purpose of this study is to compare once a week and once every other week darbepoetin alfa on the change in hemoglobin levels between the screening/baseline period and the evaluation period (weeks 25-30). This study will also assess the change in mean hemoglobin over 4 week intervals, instability of hemoglobin concentrations, darbepoetin alfa dosing requirements and red blood cell transfusions.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2002

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

June 30, 2005

Last Update Submit

December 20, 2007

Conditions

Anemia

Keywords

Hemodialysisdarbepoetin alfaClinical TrialAmgen

Outcome Measures

Primary Outcomes (1)

  • Comparison between once a week and once every other week darbepoetin alfa on the change in Hb level between the screening/baseline period and the evaluation period (weeks 25-30)

Secondary Outcomes (3)

  • Instability of Hb concentration during the evaluation period

  • Weekly dose and frequency of darbepoetin alfa during the evaluation period

  • RBC transfusions during the evaluation period.

Interventions

darbepoetin alfaDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Anemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 14, 2005

Study Start

August 1, 2002

Study Completion

September 1, 2003

Last Updated

December 28, 2007

Record last verified: 2007-12