N/A
Completed N=742
An Observational, Prospective, Safety Study of Mircera (Monopegylated Epoetin Beta) in Clinical Practice
Kidney Disease, Chronic
Source: ClinicalTrials.gov NCT02263833 ↗
Enrolled (actual)
742
Serious AEs
0.4%
Results posted
Jul 2016
Primary outcomePrimary: Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event — 3; 0.40 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event |
3; 0.40 | — |
| PRIMARY Percentage of Participants With an Adverse Drug Reaction (ADR) |
2.0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02263833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.