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

Observational Cohort Study in Chronic Kidney Disease Patients on Dialysis Initiating Treatment With Mircera During the Correction and Maintenance Phase

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01213485

Enrollment

419

Registered

2010-10-04

Start date

2010-03-31

Completion date

2011-10-31

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 study will evaluate the course of treatment, the efficacy on anemia and the safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease on dialysis. Eligible patients will be on either haemodialysis or peritoneal dialysis and treatment-naïve for or having had prior therapy with erythropoiesis stimulating agents (ESA). Data will be collected from each patient 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 * Chronic kidney disease, on dialysis for \> 3 months * Treatment-naïve or previous treatment with ESA * Initiation of treatment with Mircera for renal insufficiency associated anemia by decision of the treating physician

Exclusion criteria

* Participation in a clinical trial * Anemia due to an associated malignant pathology

Design outcomes

Primary

Measure	Time frame
Haemoglobin levels	Month 6
Mircera therapy (dosage, schedule, mode of application) in the treatment of anemia in clinical practice	Month 6

Secondary

Measure	Time frame
Safety: Incidence of adverse events	12 months
Change in haemoglobin/haematocrit	from baseline to Month 12
Biological parameters of anemia: transferrin saturation, serum ferritin, folates	12 months
Quality of life: Short Form (SF-36) questionnaire	12 months
Compliance (treatment modification or discontinuation)	12 months
Efficacy of dialysis (Kt/V, urea levels)	12 months

Countries

France

Outcome results