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Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients

NCT00701714 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 337

Last updated 2018-02-05

Study results available
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Summary

This is a randomized, controlled, double-blind, multicenter multinational safety study involving about 300 predialysis patients aged 18 years or above suffering from anemia.

Symptomatic anemia will be corrected by s.c. application of EPO HEXAL or ERYPO® in order to achieve a hemoglobin target range of 10.0 -12.0 g/dL.

Conditions

  • Anemia
  • Chronic Renal Insufficiency

Interventions

DRUG

HX575 recombinant human erythropoietin alfa

Solution for injection (s.c.)

DRUG

ERYPO

Solution for injection (s.c.)

Sponsors & Collaborators

Principal Investigators

  • Andrea Vetter, Dr. · Hexal AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-07-31
Completion
2010-01-31

Countries

  • Austria
  • Bulgaria
  • Czechia
  • France
  • Germany
  • India
  • Poland
  • Romania
  • Russia
  • Slovakia

Study Locations

More Related Trials

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 NCT00701714 on ClinicalTrials.gov