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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01690455

Enrollment

247

Registered

2012-09-21

Start date

2011-07-31

Completion date

2015-06-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Proportion of patients who achieve a hemoglobin level of >/=10 g/dl	12 months

Secondary

Measure	Time frame
Safety: incidence of adverse events	12 months

Countries

Poland

Outcome results