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Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis Patients

NCT00666835 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2023-07-03

Study results available
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Summary

This is a double-blind, randomized, multicenter, parallel-group, equivalence study involving about 462 clinically stable hemodialysis patients aged 18 years or above suffering from anemia and treated previously with a stable dose of ERYPO® intravenously.

Conditions

Interventions

DRUG

HX575 epoetin alfa Hexal AG

HX575 Solution for i.v. injection Containing 1000, 2000 and 4000 IU of rh erythropoietin

DRUG

ERYPO®, Janssen-Cilag

Solution for i.v. injection

Sponsors & Collaborators

  • Hexal AG

    collaborator INDUSTRY

  • Sandoz

    lead INDUSTRY

Principal Investigators

  • Marianne Haag-Weber, Prof. · Dialysezentrum Straubing, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2006-01-31
Completion
2006-01-31

Countries

  • Austria
  • Germany

Study Locations

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Entities

Diseases
Companies

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 NCT00666835 on ClinicalTrials.gov