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Evaluating Aranesp® in Subjects With End Stage Renal Disease onChronic Hemodialysis

A Multicenter Study Evaluating Once Weekly Intravenous Administration of Aranesp® in Subjects With End Stage Renal Disease on Chronic Hemodialysis

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00117104
Enrollment
Unknown
Registered
2005-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2009-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

End Stage Renal Disease (ESRD), Kidney Disease, Dialysis, Aranesp®, rHuEPO, Anemia, Hemoglobin, Dosing, Amgen

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).

Interventions

DRUGAranesp®

Sponsors

Amgen
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Subjects with end stage renal disease (ESRD) on hemodialysis

Exclusion criteria

- Known hypersensitivity to Aranesp® (darbepoetin alfa) or any of its excipients - Participating in an investigational drug or device trial - Patient will not be available for follow-up assessment - Patient has any disorder that compromises the ability of the patient to give written informed consent and/or to comply with study procedures

Design outcomes

Primary

MeasureTime frame
Target hemoglobin (Hgb)—

Secondary

MeasureTime frame
Distribution of hemoglobin (Hgb) values by week—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026