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

• Status: Completed
• Trial end date: 2012-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

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