A Study Comparing the Effects of Epoetin Hospira and Epogen/Epoetin Alfa (Amgen) When Administered IV in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment

NCT01170078 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2017-03-20

No results posted yet for this study

Summary

This study assessed the comparability of the pharmacokinetics (PK) of epoetin following intravenous administration of Hospira Epoetin and Epogen/Epoetin Alfa (Amgen) in patients with chronic renal failure receiving hemodialysis treatment.

Conditions

  • Chronic Renal Failure

Interventions

DRUG

Epoetin Hospira

IV dose 3 times a week.

DRUG

Epogen

IV dose 3 times a week

Sponsors & Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01170078 on ClinicalTrials.gov