A Study of Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia

Roche

Status and phase: Completed; Phase 3

Conditions: Chronic Renal Anemia

Treatments: Drug: Methoxy polyethylene glycol-epoetin beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00550680

ML20952

2006-006349-15 (EudraCT Number)

Details and patient eligibility

About

This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia. Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200, or 360 micrograms [mcg] IV injection) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start.

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults greater than or equal to (≥) 18 years of age
• Chronic renal anemia
• Stable epoetin alfa or darbepoetin alfa therapy for past 2 months
• Hemodialysis therapy for ≥3 months

Exclusion criteria

• Transfusion of red blood cells during previous 2 months
• Poorly controlled hypertension requiring hospitalization or interruption of ESA treatment in previous 6 months
• Acute or chronic bleeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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208 participants in 1 patient group

Mircera in Renal Anemia

Experimental group

Description:

Participants with chronic renal anemia who have been previously treated with erythropoiesis-stimulating agent (ESA) therapy will receive IV Mircera every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment. Subsequent doses will be adjusted to maintain Hb concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL).

Treatment:

Drug: Methoxy polyethylene glycol-epoetin beta