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

Phase 3

Terminated

• Conditions: Anemia
• Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

• Registration Number: NCT00680563
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-16
• Study First Posted: 2008-05-20
• Study Start: 2009-04
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-04
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	methoxy polyethylene glycol-epoetin beta [Mircera]	-

Primary Outcome Measures

Name	Time	Method
Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP).	Week 32

Secondary Outcome Measures

Name	Time	Method
Time to achievement of response	Throughout study
Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL	Throughout study
Mean time spent in Hb range of 10.0 - 12.0g/dL	Throughout study
Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL	Throughout study
Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy.	Throughout study