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

Roche

Status: Completed

Conditions: Anemia

Study type: Observational

Funder types: Industry

Identifiers

NCT01677767

ML25475

Details and patient eligibility

About

This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.

Enrollment: 127 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, 18 to 65 years of age, inclusive
• Patients with chronic kidney disease on dialysis
• ESA naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
• Adequate irons status as judged by the treating physician

Exclusion criteria

• Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
• Clinically significant concomitant disease or disorder as defined by protocol
• Clinical suspicion of pure red cell aplasia (PRCA)
• Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
• Transfusion of red blood cells in the previous 2 months
• Pregnant women
• Contraindications for Mircera according to local prescribing information or as judged by the investigator

Trial design

127 participants in 1 patient group

Cohort