An Observational, Prospective, Safety Study of Mircera (Monopegylated Epoetin Beta) in Clinical Practice

Roche

Status: Completed

Conditions: Kidney Disease, Chronic

Treatments: Drug: Mircera

Study type: Observational

Funder types: Industry

Identifiers

NCT02263833

ML22560

Details and patient eligibility

About

This national study was a post-marketing surveillance study conducted in Korea from 29 August 2008 to 28 August 2012 to meet local regulatory requirements for Mircera (monopegylated-epoetin beta). Prospective participant-based data collection was evaluated for safety/risk assessments and effectiveness. No specific study-related procedures are required. Participants were to be followed up as long as possible at the physician's discretion.

Enrollment: 748 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult, aged >18 years
• Participants with stage 3-5 chronic kidney disease and hemodialyzed participants
• Signed informed consent

Exclusion criteria

• Current participation in a clinical study

Trial design

748 participants in 1 patient group

Overall Participants

Description:

Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were switched to Mircera

Treatment:

Drug: Mircera