A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous MIRCERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
Overview
- Phase
- Phase 4
- Intervention
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Conditions
- Anemia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 132
- Locations
- 17
- Primary Endpoint
- Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. Patients will be treated for 12 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Investigators
Eligibility Criteria
Inclusion Criteria
- •male or female patients, \>=18 years of age;
- •chronic renal anemia;
- •Hb concentration 10.5g/dL - 12.5g/dL;
- •continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.
Exclusion Criteria
- •blood transfusion within the previous 2 months;
- •poorly controlled hypertension;
- •significant acute or chronic bleeding;
- •active malignant disease;
- •congestive heart failure (NYHA Class IV).
Arms & Interventions
Mircera
Participant with chronic renal anemia will receive methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks.
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Outcomes
Primary Outcomes
Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)
Time Frame: Weeks 8 to 12 (Last 4 weeks of treatment period)
Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 - 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not \>12.0 g/dL and not \<10.0 g/dL.
Secondary Outcomes
- Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time(At Weeks -2, 4, 8, and 12)
- Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)(SVP (Weeks -2 to -1) and TP (Weeks 8 to 12))
- Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL(Up to Week 12)
- Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths(Up to Week 14)
- Mean Change From Baseline in Heart Rate Over Time(From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12)
- Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time(From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12)
- Number of Participants With Abnormal Electrocardiogram(At Week -2 and Week 12)
- Mean Values of Serum Albumin and Serum Globulin Over Time(At Weeks -2, 4, 8, and 12)
- Mean Values of White Blood Cells and Platelets Over Time(At Weeks -2, 4, 8, and 12)
- Mean Corpuscular Volume Levels Over Time(At Weeks -2, 4, 8, and 12)
- Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time(At Weeks -2, 4, 8, and 12)
- Mean Values of Serum Sodium and Serum Potassium Over Time(At Weeks -2, 4, 8, and 12)
- Mean Values of Hypochromic Red Blood Cells Over Time(At Weeks -2, 4, 8, and 12)
- Mean Values of Serum Ferritin Over Time(At Weeks -2, 4, 8, and 12)
- Mean Values of Transferrin Over Time(At Weeks -2, 4, 8, and 12)
- Mean Values of Transferrin Saturation Over Time(At Weeks -2, 4, 8, and 12)
- Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time(At Weeks -2, 4, 8, and 12)