STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients

Phase 3

Completed

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

• Registration Number: NCT00642850
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. 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: 2007-11
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-25
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2016-05
• Results First Submitted: 2016-05-17
• Results First Submitted QC: 2016-05-17
• Last Update Submitted: 2016-05-17
• Results First Posted: 2016-06-23
• Last Update Posted: 2016-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

• Chronic renal anemia;
• Continuous stable intravenous maintenance epoetin therapy during previous month;
• Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

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Exclusion Criteria

• Transfusion of red blood cells during previous 2 months;
• Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100 millimeter of mercury (mmHg) despite medication;
• Significant acute or chronic bleeding.

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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
Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range	Week 17 up to Week 24	Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average.

Secondary Outcome Measures

Name	Time	Method
Change in Hemoglobin Concentration Between Reference (SVP) and EEP	Week -4 up to Week -1 and Week 17 up to Week 24	The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week -1) and the value during EEP (Week 17 up to Week 24) was assessed.
Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP	Week 17 up to Week 24	Mean time spent by participants with hemoglobin concentration in the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.
Number of Participants With Red Blood Cell Transfusion During the Study	Week -4 up to Week 28	Number of participant who underwent red blood cell transfusion during the study was reported.
Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP	Week 17 up to Week 24	Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.
Percentage of Participants Requiring Any Dose Adjustment	Week 1 to Week 16 and Week 17 to Week 24	Percentage of participants requiring adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.
Number of Participants With Anti-epoetin Antibody	Week -4 and at early withdrawal or Week 28