A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Methoxy Polyethylene Glycol-epoetin Beta

• Registration Number: NCT00642967
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-25
• Study Start: 2008-06
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-09
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

• chronic kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis;
• continuous stable subcutaneous maintenance Erythropoietin-Stimulating Agent (ESA) therapy during previous month.

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Exclusion Criteria

• transfusion of red blood cells during previous 2 months;
• significant acute or chronic bleeding;
• poorly controlled hypertension.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Methoxy Polyethylene Glycol-epoetin Beta	Methoxy Polyethylene Glycol-epoetin Beta	Participants will receive subcutaneous methoxy polyethylene glycol-epoetin beta every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.

Primary Outcome Measures

Name	Time	Method
Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period	Weeks 16-24

Secondary Outcome Measures

Name	Time	Method
AEs, lab parameters	Throughout study
Mean time spent in Hb range	Weeks 16-24
Mean change in Hb concentration	Between reference and Efficacy Evaluation Period
% patients maintaining Hb concentration within target range; % patients requiring dose adjustments; incidence of RBC transfusions	Weeks 16-48