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 Haemodialysis Patients With Chronic Renal Anaemia.
Overview
- Phase
- Phase 3
- Intervention
- methoxy polyethylene glycol-epoetin beta
- Conditions
- Anemia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 132
- Locations
- 20
- Primary Endpoint
- Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period
- 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 intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. 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 stable iv or sc maintenance epoetin therapy during previous 4 weeks;
- •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 requiring hospitalization or interruption of epoetin treatment in previous 6 months;
- •significant acute or chronic bleeding.
Arms & Interventions
C.E.R.A. 120, 200, or 360 mcg
Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).
Intervention: methoxy polyethylene glycol-epoetin beta
Outcomes
Primary Outcomes
Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period
Time Frame: EEP (Week 16 to Week 24)
The reference hemoglobin (Hb) value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0). The time adjusted average Hb concentration of all the values recorded during the efficacy evaluation period (EEP) was calculated for each participant and their reference Hb concentration was subtracted from this value. The percentage of participants maintaining their average Hb concentration during the EEP within +/- 1 gram/deciliter (g/dL) of their reference Hb concentration and between the Hb range 10.0 -12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24. Data missing at the end of the EEP was handled using the last value carried forward method, including any data missing due to withdrawal of participants following red blood cells (RBC) transfusion.
Secondary Outcomes
- Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period(DTP (Week 1 to Week 16), EEP (Week 16 to Week 24))
- Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24(BL (Week -4 to Week 0), Week 16, and Week 24)
- Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24(BL (Week -4 to Week 0), Week 16, and Week 24)
- Mean Change From Baseline in Weight at Week 16 and Week 24(BL (Week -4 to Week 0), Week 16, and Week 24)
- Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period(EEP (Week 16 to Week 24))
- Mean Change in Hemoglobin Concentration Between the Stability Verification Period and the Efficacy Evaluation Period(SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24))
- Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period(EEP (Week 16 to Week 24))
- Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period(DTP (Week 1 to Week 16), EEP (Week 16 to Week 24))
- Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period(EEP (Week 16 to Week 20))
- Mean Change From Baseline in Ferritin at Week 16 and Week 24(BL (Week -4 to Week 0), Week 16, and Week 24)
- Mean Change From Baseline in Hematocrit at Week 16 and Week 24(BL (Week -4 to Week 0), Week 16, and Week 24)
- Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24(BL (Week -4 to Week 0), Week 16, and Week 24)
- Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24(BL (Week -4 to Week 0), Week 16, and Week 24)
- Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24(BL (Week -4 to Week 0), Week 16, and Week 24)
- Mean Change From Baseline in Hemoglobin at Week 16 and Week 24(BL (Week -4 to Week 0), Week 16, and Week 24)
- Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24(BL (Week -4 to Week 0), Week 16, and Week 24)
- Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24(BL (Week -4 to Week 0), Week 16, and Week 24)
- Number of Participants Taking Concomitant Medications(Up to Week 28)
- Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24(Baseline (Week -4 to Week 0), Week 16, and Week 24)
- Number of Participants With Any Adverse Events and Serious Adverse Events(Up to Week 28)
- Number of Participants With Reports of Anti-erythropoietin Antibodies(Up to Week 24)
- Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period(Week 1 to Week 24)