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

Completed

• Conditions: Kidney Disease, Chronic
• Interventions: Drug: Mircera

• Registration Number: NCT02263833
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-13
• Results First Submitted: 2016-06-17
• Results First Submitted QC: 2016-06-17
• Status Verified: 2016-07
• Results First Posted: 2016-07-28
• Last Update Submitted: 2016-07-29
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 748

Inclusion Criteria

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

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Exclusion Criteria

• Current participation in a clinical study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event	At physician's discretion, up to 4 years	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.
Percentage of Participants With an Adverse Drug Reaction (ADR)	At physician's discretion, up to 4 years	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.