Trial intelligence / Profile preview

Mircera Maintenance in Non-Dialysis CKD Patients

NCT00642967Phase 3

Key facts

Status: Completed
Start: Jun 2008
Primary completion: Aug 2010
Countries: 1
Sponsor: Roche
Modality: rProtein (Recombinant Protein), Biologic

Drugs: methoxy polyethylene glycol-epoetin beta
Conditions: anemia of chronic kidney disease (CKD-A)

Overview

Phase 3, open-label, single-arm trial of methoxy polyethylene glycol-epoetin beta in anemia of chronic kidney disease (CKD-A), sponsored by Roche. Primary endpoint: Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL at 24 weeks. Started Jun 2008; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Methoxy Polyethylene Glycol-epoetin Beta
Monthly subcutaneous Mircera

Who it enrols

Patients with chronic kidney disease stage 3 or 4, not requiring dialysis, with chronic renal anemia, currently on stable subcutaneous ESA therapy. Excludes patients with recent RBC transfusions, significant bleeding, or poorly controlled hypertension.

Endpoints

Primary

Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL24 weeks

Secondary

Mean change in Hb concentration24 weeks
Mean time spent in Hb range24 weeks
% patients maintaining Hb concentration within target range48 weeks
% patients requiring dose adjustments48 weeks
incidence of RBC transfusions48 weeks
AEs, lab parameters48 weeks

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