drugset
drugset / Trial / NCT00680563

A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.

NCT00680563 ↗

Phase 3 Terminated 4 enrolled Hoffmann-La Roche
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Timeline

Start
2009-04
Primary completion
2010-01
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Subject methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 1.2 ug/kg Subcutaneous

Indications

anemia