drugset / Trial / NCT00081471

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

NCT00081471

Phase 3 Completed 324 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2004-06
Primary completion
2006-07
Completion
2006-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Darbepoetin alfa Protein / enzyme biologic 0.45 ug/kg Subcutaneous
Subject methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 0.6 ug/kg Subcutaneous

Indications