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A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.

NCT00077623 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2016-05-25

Study results available
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Summary

This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Conditions

Interventions

DRUG

epoetin alfa or beta

iv 3 times weekly, as prescribed

DRUG

methoxy polyethylene glycol-epoetin beta (Mircera)

60, 100 or 180 micrograms sc (starting dose) every 2 weeks

DRUG

methoxy polyethylene glycol-epoetin beta (Mircera)

60, 100 or 180 micrograms sc (starting dose) every 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2005-09-30
Completion
2005-09-30

Countries

  • United States
  • Belgium
  • Brazil
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • New Zealand
  • Panama
  • Poland
  • Puerto Rico
  • South Africa
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • United Kingdom

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 NCT00077623 on ClinicalTrials.gov