A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera® for the Maintenance of Haemoglobin Levels in Patients With Chronic Renal Anaemia Who Are Not on Dialysis
Overview
- Phase
- Phase 4
- Intervention
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Conditions
- Anemia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 191
- Locations
- 10
- Primary Endpoint
- Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Investigators
Eligibility Criteria
Inclusion Criteria
- •adult patients, \>=18 years of age;
- •chronic renal anemia;
- •continuous maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose.
Exclusion Criteria
- •transfusion of red blood cells during previous 2 months;
- •poorly controlled hypertension;
- •significant acute or chronic bleeding;
- •active malignant disease (except non-melanoma skin cancer).
Arms & Interventions
1
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Outcomes
Primary Outcomes
Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)
Time Frame: EEP (Weeks 17 to 24)
The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period \[SVP\]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.
Secondary Outcomes
- Average Dose of Mircera Per Month(Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24)
- Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP(EEP (Weeks 17 to 24))
- Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP(Weeks 1 to 24)
- Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP(Weeks 1 to 24)
- Change in Hemoglobin Concentration Between SVP and the EEP(SVP (Baseline), and EEP (Weeks 17 to 24))