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A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis

NCT00081471 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2016-11-02

No results posted yet for this study

Summary

This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Conditions

Interventions

DRUG

darbepoetin alfa

0.45 micrograms/kg sc (starting dose) weekly

DRUG

methoxy polyethylene glycol-epoetin beta [Mircera]

0.6 micrograms/kg sc (starting dose) once 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
2006-07-31
Completion
2006-07-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Puerto Rico
  • Spain
  • Sweden
  • 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 NCT00081471 on ClinicalTrials.gov