An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) as Maintenance Treatment in Patients With Chronic Renal Anemia on Haemodialysis

Roche

Status: Completed

Conditions: Anemia, Kidney Disease, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT01422824

ML25067

Details and patient eligibility

About

This prospective observational study will evaluate the safety and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on haemodialysis in maintenance ESA treatment. Data will be collected from patients receiving once monthly Mircera according to standard of care and local labelling during 12 months of treatment.

Enrollment: 185 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• Stage IV chronic kidney disease, on haemodialysis
• Chronic renal anemia, on maintenance ESA treatment
• Hemoglobin concentration between 10.0 an 12 g/dL
• Continuous maintenance epoetin therapy with the same dosing interval during the previous month

Exclusion criteria

• Contraindications to ESA treatment (e.g. hypersensitivity, non-controlled hypertension)
• Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
• Anemia due to hemolysis, pure red cell aplasia

Trial design

185 participants in 1 patient group

Cohort