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

Roche

Status: Completed

Conditions: Anemia

Study type: Observational

Funder types: Industry

Identifiers

NCT01213485

ML22643

Details and patient eligibility

About

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.

Enrollment: 419 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

419 participants in 1 patient group

Cohort