A Single-arm, Open Label Multicenter Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of C.E.R.A. for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia
Overview
- Phase
- Phase 3
- Intervention
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Conditions
- Anemia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 200
- Primary Endpoint
- Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. 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;
- •hemodialysis or peritoneal dialysis, with same mode of dialysis for \>=3 months before and throughout screening period;
- •continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months.
Exclusion Criteria
- •transfusion of red blood cells during previous 2 months;
- •poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months;
- •significant acute or chronic bleeding such as overt gastrointestinal bleeding;
- •hemolysis;
- •folic acid and vitamin B12 deficiency.
Arms & Interventions
RO0503821 (C.E.R.A.), 1x/4weeks
Eligible participants started RO0503821 (Continuous Erythropoietin Receptor Activator \[C.E.R.A\]) intravenously, at a dose of 120, 200 or 360 microgram (µg) every four weeks. The dose of C.E.R.A was based on the epoetin alfa or beta dose of\<8000, 8000-16000, or \>16000 international units (IU)/week, administered during the stability verification period (SVP) of 4 weeks. The SVP period was followed by dose titration period (DTP) of 16 weeks, efficacy evaluation period (EEP) of 8 weeks and long term safety period (LTSP) of 28 weeks
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Outcomes
Primary Outcomes
Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP
Time Frame: EEP (Week 16 to Week 24)
All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The percentage of participants maintaining their mean Hemoglobin (Hb) concentration within +/- 1 gram/deciliter (g/dL) of their reference Hb and between 10.5 -12.5 g/dL is presented during the EEP. The EEP is defined as Week 16 to Week 24
Secondary Outcomes
- Mean Change in Hb Concentration From Baseline to the EEP(Baseline (Week -4 to Week -1), EEP (Week 16 to Week 24))
- Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP(EEP (Week 16 to Week 24))
- Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP(EEP (Week 16 to Week 24))
- Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP(DTP (Week 1 to Week 16), EEP (Week 16 to Week 24) and LTSP (Week 24 to Week 44))
- Number of Participants With Red Blood Cell Transfusion(Up to 3 years)