An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or Dialysis

A Prospective Study Evaluating the Efficacy and Safety of Mircera in Patients With CKD in Predialysis and Dialysis.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01309295

Enrollment

250

Registered

2011-03-07

Start date

2010-11-30

Completion date

2012-11-30

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, Kidney Disease, Chronic

Brief summary

This prospective observational study will assess the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each patient will be collected over 12 months of treatment.

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 * Chronic kidney disease, in pre-dialysis or dialysis * Appropriate for treatment with Mircera according to current guidelines and Summary of Product Characteristics

Exclusion criteria

* Anemia due to non-renal causes * Pregnant or lactating women * Uncontrolled hypertension * Known hypersensitivity to methoxy polyethylene glycol-epoetin beta

Design outcomes

Primary

Measure	Time frame
Achievement of target hemoglobin (Hb) range of 10-12 g/dL according to Kidney Disease Outcomes Quality Initiative (KDQOI) guidelines	2 years
Maintenance of target Hb range (10-12 g/dL)	2 years
Safety: Incidence of adverse events	2 years

Secondary

Measure	Time frame
Correlation between baseline clinical variables and time on target Hb level	2 years
Effect of compliance to treatment on Hb levels	2 years
Dosing pattern in clinical practice, including dose adaptations	2 years
Frequency of visits and laboratory assessments	2 years

Countries

Albania

Outcome results