A Randomized, Open Label Study to Compare the Effect of Once Monthly Administration of Subcutaneous Mircera Versus Epoetin Alfa on Maintenance of Hemoglobin Levels, Safety and Tolerability 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
- 233
- Primary Endpoint
- Percentage of Participants Maintaining Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
This 2 arm study will compare the efficacy and safety of monthly administration of subcutaneous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will be randomized to receive either monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. 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;
- •regular hemodialysis with the same schedule of dialysis for \>=12 weeks;
- •maintenance therapy with subcutaneous epoetin alfa at the same administration interval for 4 weeks.
Exclusion Criteria
- •transfusion of red blood cells during previous 2 months;
- •poorly controlled hypertension requiring interruption of epoetin alfa in previous 6 months;
- •acute or chronic bleeding;
- •active malignant disease (except non-melanoma skin cancer).
Arms & Interventions
1
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
2
Intervention: Epoetin alfa
Outcomes
Primary Outcomes
Percentage of Participants Maintaining Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period
Time Frame: EEP (Week 29 to Week 36)
The target hemoglobin (Hb) range was defined as Hb concentration (gram/deciliter \[g/dL\]) between 10.5 and 12.5 g/dL during the efficacy evaluation period (EEP). EEP was from Week 29 to Week 36.
Secondary Outcomes
- Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period(EEP (Week 29 to Week 36))
- Number of Participants Who Required Dose Adjustments During the Dose Titration Period(DTP (Weeks 0 to 28))
- Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period(EEP (Weeks 29 to 36))
- Mean Values of Hemoglobin Concentration at Baseline and Week 36(Baseline and Week 36)
- Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40(From Baseline to Week 40)
- Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period(EEP (Weeks 29 to 36))
- Number of Participants Received Red Blood Cells Transfusions(Up to Week 28)
- Mean Values of Hematocrit at Baseline and Week 36(Baseline and Week 36)
- Mean Values of Mean Corpuscular Volume at Baseline and Week 36(Baseline and Week 36)
- Mean Values of Leukocytes and Platelets Count at Baseline and Week 36(Baseline and Week 36)
- Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36(Baseline and Week 36)
- Mean Values of Ferritin Concentration at Baseline and Week 36(Baseline and Week 36)
- Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period(Baseline (Weeks -4 to 0) and at EEP (Weeks 29 to 36))
- Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36(Baseline and Week 36)
- Mean Values of Transferrin Saturation at Baseline and Week 36(Baseline and Week 36)
- Number of Participants With Abnormal Changes in ECG From Baseline to Week 40(From Baseline to Week 40)
- Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36(Baseline and Week 36)
- Number of Participants With Adverse Events and Serious Adverse Events(Up to Week 40)