NCT00117104

Brief Summary

The purpose of this study is to assess the Aranesp® dose administered intravenously (IV) once weekly to maintain hemoglobin (Hgb) levels in hemodialysis subjects who are either recombinant human erythropoietin (rHuEPO) naïve or subjects converted from rHuEPO therapy administered IV thrice weekly (TIW).

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2005

Completed
Last Updated

October 16, 2009

Status Verified

October 1, 2009

First QC Date

June 30, 2005

Last Update Submit

October 15, 2009

Conditions

Keywords

End Stage Renal Disease (ESRD)Kidney Disease, DialysisAranesp®, rHuEPOAnemia, HemoglobinDosing, Amgen

Outcome Measures

Primary Outcomes (1)

  • Target hemoglobin (Hgb)

Secondary Outcomes (1)

  • Distribution of hemoglobin (Hgb) values by week

Interventions

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

Kidney Failure, ChronicKidney DiseasesAnemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHematologic 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 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 4, 2005

Last Updated

October 16, 2009

Record last verified: 2009-10