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

Kidney Disease, Chronic Clinical Trial

Official title:

Post Marketing Surveillance of Mircera®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263833
• Other study ID #: ML22560
• Status: Completed
• Phase: N/A
• First received: October 8, 2014
• Last updated: March 1, 2016
• Start date: September 2009
• Est. completion date: August 2012

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea:Ministry of Food and Drug Safety (MFDS)
• Study type: Observational

Clinical Trial 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 patient-based data collection was evaluated for safety/risk assessments and effectiveness. No specific study-related procedures are required. Patients were to be followed up as long as possible at the physician's discretion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 748
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult, aged >18 years

• Patients with stage 3-5 chronic kidney disease and hemodialyzed patients

• Signed informed consent

Exclusion Criteria:

• Current participation in a clinical study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Kidney Disease, Chronic
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious adverse events (AEs)/adverse drug reactions (ADRs)		At physician's discretion, up to 4 years	No
Secondary	Percentage of patients having a hemoglobin concentration in accordance with EMEA recommendations (10-12 g/dl) during the evaluation period		Up to 4 years	No
Secondary	Percentage of patients having an increase in Hb level of at least 1 g/dl from baseline and reaching the target Hb level with red blood cell transfusion		Up to 4 years	No