A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00661388

ML21524

Details and patient eligibility

About

This single arm study will assess the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with erythropoietin stimulating agents (ESA). Eligible patients will receive monthly subcutaneous injections of Mircera at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• chronic renal anemia;
• predialysis stage;
• 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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75 participants in 1 patient group

Continuous erythropoietin receptor activator (C.E.R.A.)

Experimental group

Description:

Eligible participants will be administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. will be 1.2 micrograms/kilogram. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin within the target range of 10.0 and 12.0 grams/deciliter.

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]