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

Roche

Status and phase: Completed; Phase 4

Conditions: Anemia

Treatments: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01342640

ML25300

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]