An Observational Study of Mircera in Renal Anemia Correction In Dialysed Patients During Daily Clinical Practice

This observational, multi-center study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in renal anemia correction in dialysed patients in daily clinical practice. Patient will receive Mircera according to local summary of product characteristics. Data will be collected for 12 months.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bartoszyce, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients, >/=18 years of age
Adequate iron status
Signed informed consent form

Exclusion criteria

Anemia due to non-renal causes
Where investigator considers the patient unsuitable for inclusing for other reasons (e.g. severe co-morbidities as active bleeding, infections or cancer)
Pregnant or lactating female patients
Any contraindications against treatment with Mircera (according to local Summary of Product Characteristics)

Treatment and study plan

Primary outcomes

Proportion of patients who achieve a hemoglobin level of >/=10 g/dl

Time frame: 12 months

Secondary outcomes

Safety: incidence of adverse events

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Non-interventional Study to Assess the Efficacy of Mircera for Renal Anemia Correction in Dialysis Patients in Everyday Clinical Practice in Poland.

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Sep 21, 2012
Registry last updated: Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed