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Efficacy Study of Two Formulations of Erythropoietin

NCT01184495 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2017-02-27

No results posted yet for this study

Summary

A double-blind, randomized trial aimed to compare the efficacy of two formulations of erythropoietin in patients with chronic renal failure on hemodialysis

Conditions

  • Comparison of the Efficacy of Two Formulations of Epoetin in Patients Undergoing Hemodialysis

Interventions

DRUG

Epoetin Alfa-BioManguinhos

Subcutaneous administration of EPO-BioManguinhos

DRUG

Epoetin Alfa-BioSimilar

Subcutaneous administration of EPO-BioSimilar

Sponsors & Collaborators

  • Rio Grande do Sul State Health Department - SES/RS

    collaborator OTHER_GOV

  • Oswaldo Cruz Foundation

    collaborator OTHER

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Paulo Dornelles Picon · Hospital de Clinicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-12-31
Completion
2009-01-31

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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 NCT01184495 on ClinicalTrials.gov