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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

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