A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Methoxy polyethylene glycol-epoetin beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00660023

ML20752

2006-005621-28

Details and patient eligibility

About

This single-arm study will assess the efficacy and safety of monthly administration of intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine clinical practice in Hungary. Participants currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been receiving.

Enrollment: 124 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
• Continuous stable intravenous or subcutaneous maintenance epoetin or darbepoetin therapy during previous month
• Regular long-term hemodialysis therapy with the same mode of dialysis for the previous 3 months

Exclusion criteria

• Transfusion of red blood cells during previous 2 months
• Poorly controlled hypertension
• Significant 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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124 participants in 1 patient group

Mircera in Renal Anemia

Experimental group

Description:

Participants with chronic renal anemia previously treated with ESA therapy will receive intravenous Mircera, also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose will be determined by the dose of ESA received prior to administration of study treatment, and subsequent doses will be adjusted to achieve target Hb concentrations.

Treatment:

Drug: Methoxy polyethylene glycol-epoetin beta