Observational Study of MIRCERA in Users of Self-Application and Multidose Systems

Roche

Status: Completed

Conditions: Renal Anemia of Chronic Kidney Disease

Treatments: Device: MIRCERA

Study type: Observational

Funder types: Industry

Identifiers

NCT02540213

ML21387

Details and patient eligibility

About

This non-interventional, observational study investigates the efficiency, safety and acceptance of MIRCERA in participants, who received erythropoiesis stimulating agent (ESA) using a self-application system. For each participant, the investigator documents 9 months of treatment with Mircera with respect to efficacy, safety and acceptance.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Anemia caused by CKD only
• Life expectancy of more than (>) 9 months in the judgment of the attending physician
• Ferritin >200 micrograms per liter (mcg/L) in accordance with the relevant guidelines
• The time point of changing to Mircera was only 3 months ago at the longest

Exclusion criteria

N/A

Trial design

240 participants in 1 patient group

MIRCERA Ready-To-Use-Syringe

Description:

Participants will use MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta 0.6 micrograms per kilogram \[mcg/kg\]) every 2 weeks (q2w) up to 9 months

Treatment:

Device: MIRCERA