A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
Overview
- Phase
- Phase 3
- Intervention
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Conditions
- Anemia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 188
- Primary Endpoint
- Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
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.
Arms & Interventions
1
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Outcomes
Primary Outcomes
Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range
Time Frame: 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 Outcomes
- Change in Hemoglobin Concentration Between Reference (SVP) and EEP(Week -4 up to Week -1 and Week 17 up to Week 24)
- Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP(Week 17 up to Week 24)
- Number of Participants With Red Blood Cell Transfusion During the Study(Week -4 up to Week 28)
- Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP(Week 17 up to Week 24)
- Percentage of Participants Requiring Any Dose Adjustment(Week 1 to Week 16 and Week 17 to Week 24)
- Number of Participants With Anti-epoetin Antibody(Week -4 and at early withdrawal or Week 28)