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

Post Marketing Surveillance of Mircera®

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.

Study Overview

• Status: Completed
• Conditions: Kidney Disease, Chronic
• Intervention / Treatment: Drug: Mircera

• Study Type: Observational
• Enrollment (Actual): 748

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with chronic renal anemia regardless of pre-dialysis / dialysis in Korea. Participants who were prescribed Mircera by their physician according to the local Korean Mircera label, for the treatment of anemia associated with chronic kidney disease who require ESA therapy could be included in the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Overall Participants; Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were switched to Mircera	Drug: Mircera; Participants received Mircera according to individualized physician-prescribed regimen.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Percentage of ESA Naïve Participants Having an Increase in Hemoglobin (Hb) Level of at Least 1 g/dL From Baseline and Reaching the Hb Level Greater Than or Equal to (>/=) 11 g/dL Without Red Blood Cell Transfusion	Up to 4 years
Percentage of Participants on ESA Therapy Who Were Switched to Mircera Having a Hemoglobin Concentration in the Range of 10 to 12 g/dL	Up to 4 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: October 8, 2014
• First Submitted That Met QC Criteria: October 8, 2014
• First Posted (Estimate): October 13, 2014

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: July 29, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: ML22560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO