A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.

Phase 3

Withdrawn

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

• Registration Number: NCT00560547
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single arm study will assess the long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darboepoetin alfa or epoetin alfa maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/4 weeks (based on the ESA dose administered on week-1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10.5-12.5g/dL. 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
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-16
• Study First Submitted QC: 2007-11-16
• Study First Posted: 2007-11-19
• Study Completion: 2009-10
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-23
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• adult patients, >=18 years of age;
• chronic renal anemia;
• regular long-term hemodialysis therapy with the same mode of dialysis for >=3 months;
• continuous iv or sc maintenance ESA treatment during previous 2 months.

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Exclusion Criteria

• transfusion of red blood cells during previous 2 months;
• significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
• active malignant disease (except non-melanoma skin cancer).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	methoxy polyethylene glycol-epoetin beta	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients maintaining average Hb concentration within target range during evaluation period	Weeks 17-24

Secondary Outcome Measures

Name	Time	Method
Change in Hb concentration between reference and evaluation period; mean time spent in, and percentage of patients maintaining Hb within target range	Weeks 17-24
Dose adjustments; RBC transfusions	Throughout study
AEs, laboratory parameters, vital signs	Throughout study