CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 748 enrolled
Drug / intervention
Mirceradrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02263833
NCT02263833N/ACompleted

Post Marketing Surveillance of Mircera®

Hoffmann-La Roche·observational·Posted Oct 13, 2014·Updated Sep 7, 2016

In Brief

An observational study evaluating Mircera for Kidney Disease, Chronic. Completed, enrolled 748 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 13, 2014
Enrollment StartSep 1, 2009
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.7 years ago

Interventions

Mirceradrug

Participants received Mircera according to individualized physician-prescribed regimen.