A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.

Roche

Status and phase: Completed; Phase 4

Conditions: Anemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00737711

ML21822

Details and patient eligibility

About

This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 189 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female patients, >=18 years of age;
• chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);
• no prior erythropoietin stimulating agent (ESA) therapy.

Exclusion criteria

• blood transfusion within the previous 4 weeks;
• poorly controlled hypertension;
• significant acute or chronic bleeding;
• active malignant disease;
• congestive heart failure (NYHA Class IV).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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189 participants in 1 patient group

Mircera

Experimental group

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]