drugset / Trial / NCT00462384

A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease.

NCT00462384

Phase 3 Terminated 39 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kilogram \[mcg/kg\]). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Timeline

Start
2008-02
Primary completion
2011-04
Completion
2011-04

Drugs

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

Indications