drugset / Trial / NCT01342640

A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia

NCT01342640

Phase 4 Completed 70 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.

Timeline

Start
2011-07-18
Primary completion
2012-11-30
Completion
2012-11-30

Drugs

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

Indications