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

NCT00077610 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 673

Last updated 2017-01-13

Study results available
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Summary

This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv 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

intravenously 3 times weekly for 52 weeks, as prescribed

DRUG

RO0503821 (1x/2 Weeks)

60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks.

DRUG

RO0503821 (1x/4 Weeks)

120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 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
2004-02-29
Primary Completion
2005-08-31
Completion
2005-08-31

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Norway
  • Spain
  • Switzerland

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 NCT00077610 on ClinicalTrials.gov