A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia

• Status: Completed
• Trial end date: 2012-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Adult patients, age >/=18 years

• Diagnosis of chronic renal anemia

• Not on dialysis

• Hemoglobin concentration <10 g/dl

• No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start

• Estimated glomerular filtration rate (EGFR) <60 ml/min and >/=20 ml/min

• Adequate iron status

Exclusion Criteria:

• Transfusion of red blood cells during the previous 2 months

• Poorly controlled hypertension

• Significant acute or chronic bleeding, e.g. gastrointestinal bleeding

• Active malignant disease (except non-melanoma skin cancer)

• Hemolysis

• Hemoglobinopathies, e.g. sickle-cell disease, thalassemia