An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM)

Roche

Status: Completed

Conditions: Anemia

Treatments: Drug: Mircera

Study type: Observational

Funder types: Industry

Identifiers

NCT01417377

ML25368

Details and patient eligibility

About

This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease previously on treatment with short-acting epoetin alpha. Data will be collected for 6 months.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, age 18 years or above
• Chronic kidney disease (CKD) with anemia
• Patients on dialysis receiving short-acting epoetin (EPO)
• Serum ferritin level >/=100 ng/ml or transferrin saturation (TSAT) >/=20%

Exclusion criteria

• Patients unwilling to give informed consent
• Uncontrolled hypertension
• Transfusion of red blood cells within 8 weeks of the start of Mircera treatment
• Relevant acute or chronic bleeding history
• Hemolysis
• Hemoglobinopathies
• Pure red cell aplasia

Trial design

22 participants in 1 patient group

Cohort

Description:

Mircera

Treatment:

Drug: Mircera