A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.

Roche

Status and phase: Terminated; Phase 3

Conditions: Anemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00680563

ML21467

Details and patient eligibility

About

This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections 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: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• chronic renal anemia;
• no ESA therapy during previous 3 months;
• adequate iron status;
• rapid chronic kidney disease progression.

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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

1

Experimental group

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]