A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anemia

Intervention / Treatment
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* Drug: methoxy polyethylene glycol-epoetin beta [Mircera]


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mircera<br>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. | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* iv (120, 200 or 360 micrograms) every 4 weeks for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12) | 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. | Weeks 8 to 12 (Last 4 weeks of treatment period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12) | The mean change in Hb concentration between reference stability verification period (SVP) and in last 4 weeks (Weeks 8 to 12) of treatment period (TP) was reported. Duration for SVP was 2 weeks followed by treatment period of 12 weeks. 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 hemoglobin +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL. | 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 | Mean time participants spent having hemoglobin range of 10.0 to 12.0 g/dL was reported. 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 hemoglobin +/- 1 gram per deciliter but not >12.0 g/dL and not <10.0 g/dL. | Up to Week 12 | 
| Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths | Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and deaths in the overall study were reported. An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | Up to Week 14 | 
| Mean Change From Baseline in Heart Rate Over Time | Mean change from Baseline (Week -1) to end of the treatment (Week 12) in heart rate was reported. Baseline measure was considered as (Week -1) evaluation for this parameter. | 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 | Mean change from Baseline (Week -2) to end of the treatment (Week 12) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after dialysis was reported. Baseline measure was considered as (Week -2) evaluation for this parameter. | From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12 | 
| Number of Participants With Abnormal Electrocardiogram | Participants with abnormal electrocardiogram were reported. | At Week -2 and Week 12 | 
| Mean Values of White Blood Cells and Platelets Over Time | Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported. | At Weeks -2, 4, 8, and 12 | 
| Mean Values of Hypochromic Red Blood Cells Over Time | Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported. | At Weeks -2, 4, 8, and 12 | 
| Mean Corpuscular Volume Levels Over Time | Mean corpuscular volume (MCV) is a measure of the average red blood cell volume. MCV levels at Weeks -2, 4, 8, and 12 were reported. | At Weeks -2, 4, 8, and 12 | 
| Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time | Mean values of serum iron and total iron binding capacity (TIBC) were reported. | At Weeks -2, 4, 8, and 12 | 
| Mean Values of Serum Ferritin Over Time | Mean values of serum ferritin were reported. | At Weeks -2, 4, 8, and 12 | 
| Mean Values of Transferrin Over Time | Mean values of transferrin were reported. | At Weeks -2, 4, 8, and 12 | 
| Mean Values of Transferrin Saturation Over Time | Mean values of Transferrin Saturation (TSAT) were reported. | At Weeks -2, 4, 8, and 12 | 
| Mean Values of Serum Albumin and Serum Globulin Over Time | Mean values of serum albumin and serum globulin were reported. | At Weeks -2, 4, 8, and 12 | 
| Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time | Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported. | At Weeks -2, 4, 8, and 12 | 
| Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time | Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported. | At Weeks -2, 4, 8, and 12 | 
| Mean Values of Serum Sodium and Serum Potassium Over Time | Mean values of serum sodium and serum potassium were reported. | At Weeks -2, 4, 8, and 12 |