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

Roche

Status: Completed

Conditions: Anemia, Kidney Disease, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT01309295

ML25465

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

250 participants in 1 patient group

Cohort