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

Roche

Status and phase: Completed; Phase 4

Conditions: Anemia

Treatments: Drug: methoxy polyethylene glycol-epoetin beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00642668

ML21348

Details and patient eligibility

About

This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants, >=18 years of age;
• Chronic renal anemia;
• No ESA therapy during previous 3 months.

Exclusion criteria

• Transfusion of red blood cells during previous 2 months;
• Poorly controlled hypertension requiring hospitalization in previous 6 months;
• 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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35 participants in 1 patient group

Methoxy Polyethylene Glycol-Epoetin Beta

Experimental group

Description:

Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta