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

Phase 3TerminatedNCT00680563

Hoffmann-La Roche4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]DRUG

sc every month (starting dose 1.2 micrograms/kg)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (22)

Unnamed facility

Buenos Aires, Argentina

Unnamed facility

La Plata, Argentina

Unnamed facility

San Miguel de Tucumán, Argentina

Outcomes

Primary Outcomes

Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP).

Time frame: Week 32

Secondary Outcomes

Time to achievement of response

Time frame: Throughout study

Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL

Time frame: Throughout study

Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL

Time frame: Throughout study

Mean time spent in Hb range of 10.0 - 12.0g/dL

Time frame: Throughout study

Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy.

Time frame: Throughout study

Data from ClinicalTrials.gov

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