An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Stage V Chronic Kidney Disease Participants on Hemodialysis

Roche

Status: Completed

Conditions: Anemia

Treatments: Drug: Methoxy polyethylene glycol epoetin beta

Study type: Observational

Funder types: Industry

Identifiers

NCT01940484

ML22344

Details and patient eligibility

About

This observational study will evaluate the efficacy and use of Methoxy polyethylene glycol-epoetin beta (Mircera) in participants with Stage V chronic kidney disease on hemodialysis receiving an erythropoietin prior to study entry. Attending physicians should have made the decision of placing the participant on methoxy polyethylene glycol epoetin beta in advance and not related to the study. The therapy will be administered by the attendant treating physician according to specifications in the package insert guidelines and to the routine of the site.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with chronic renal anemia with Stage V chronic kidney disease on hemodialysis and with a hemoglobin level of 10.0 - 13.0 grams per deciliter (g/dL)
• Participants had to be receiving an ESA prior to entering the study
• Female participants of childbearing age had to be using effective contraceptive methods

Exclusion criteria

• As per approved package insert
• Any contraindication to ESA treatment

Trial design

98 participants in 1 patient group

Chronic Renal Anemia Participants

Description:

Participants with chronic kidney disease and who are on hemodialysis and on methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia will be observed for a period of 6-12 months.

Treatment:

Drug: Methoxy polyethylene glycol epoetin beta