A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease

Hoffmann-La Roche0 sites182 target enrollmentFebruary 2004

ConditionsAnemia

Interventionsmethoxy polyethylene glycol-epoetin beta [Mircera]epoetin

Drugsepoetin methoxy polyethylene glycol-epoetin beta [Mircera]

Overview

Phase: Phase 3
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Enrollment: 182
Primary Endpoint: Hemoglobin response rate
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently 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.

Registry

clinicaltrials.gov

Start Date

February 2004

End Date

June 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•adult patients \>=18 years of age;
•chronic renal anemia;
•dialysis therapy for at least 2 weeks before screening.

Exclusion Criteria

•women who are pregnant, breastfeeding or using unreliable birth control methods;
•administration of any investigational drug within 4 weeks before screening.