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

Study Overview
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Brief Summary
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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.

Official Title
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Post Marketing Surveillance of Mircera®

Conditions
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Kidney Disease, Chronic

Intervention / Treatment
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* Drug: Mircera


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Overall Participants<br>Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were switched to Mircera | Drug: Mircera<br>* Participants received Mircera according to individualized physician-prescribed regimen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event | An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above. | At physician's discretion, up to 4 years | 
| Percentage of Participants With an Adverse Drug Reaction (ADR) | ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as definitely related,probably related, possibly related, and unknown by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as Unexpected. An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. | At physician's discretion, up to 4 years |