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

NCT00081484 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2016-11-02

No results posted yet for this study

Summary

This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Conditions

Interventions

DRUG

epoetin alfa or beta

iv or sc, as prescribed

DRUG

methoxy polyethylene glycol-epoetin beta [Mircera]

30, 50 or 90 micrograms iv or sc (starting dose) every 2 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
2004-06-30
Primary Completion
2006-03-31
Completion
2006-03-31

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Poland
  • Portugal
  • Puerto Rico
  • Spain
  • 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 NCT00081484 on ClinicalTrials.gov