A Study of Subcutaneous 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 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.

Official Title
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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.

Conditions
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Anemia

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


Participation Criteria
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Eligibility Criteria
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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).

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* 120, 200 or 360 micrograms sc monthly (starting dose)<br>|
| Active Comparator: 2<br> | Drug: Epoetin alfa<br>* As prescribed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | EEP (Week 29 to Week 36) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period | The Baseline (Safety Verification Period) was from Week - 4 to Week -1. | Baseline (Weeks -4 to 0) and at EEP (Weeks 29 to 36) | 
| Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period | Percentage of participants maintaining individual Hb concentration within the Hb range 10.5 - 12.5 g/dL were reported during EEP. The EEP was from Week 29 to Week 36 of the study period. | EEP (Weeks 29 to 36) | 
| Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period | Mean time to maintain Hb in the range of 10.5-12.5 g/dL during EEP is presented. | EEP (Week 29 to Week 36) | 
| Number of Participants Who Required Dose Adjustments During the Dose Titration Period | The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28. | DTP (Weeks 0 to 28) | 
| Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period | The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Efficacy Evaluation Period (EEP). The EEP was from Week 29 to Week 36. | EEP (Weeks 29 to 36) | 
| Number of Participants Received Red Blood Cells Transfusions | The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported. For this study, blood transfusion was reported during the titration period. No transfusion occurred in the EEP. | Up to Week 28 | 
| Mean Values of Hemoglobin Concentration at Baseline and Week 36 | The mean Hb concentration for each participant throughout the study was estimated. Summary data of mean values of Hb concentration at Baseline and Week 36 are presented. | Baseline and Week 36 | 
| Mean Values of Hematocrit at Baseline and Week 36 | Hematocrit is the volume percentage of red blood cells in blood. The mean hematocrit for each participant was estimated throughout the study. Summary data of mean values of Hb at Baseline and Week 36 are presented. | Baseline and Week 36 | 
| Mean Values of Mean Corpuscular Volume at Baseline and Week 36 | Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant throughout the study was estimated. Summary data of mean values of MCV concentration at Baseline and Week 36 are presented. | Baseline and Week 36 | 
| Mean Values of Leukocytes and Platelets Count at Baseline and Week 36 | The mean values of laboratory parameters: leukocytes and platelets count for each participant was estimated throughout the study. Summary data of mean values of leukocytes and platelets count at Baseline and Week 36 are presented. | Baseline and Week 36 | 
| Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36 | Mean values of laboratory parameters: creatinine, potassium, phosphate, parathyroid hormone (PTH), iron and total iron binding capacity (TIBC) for each participant were estimated throughout the study. Summary data of mean values of laboratory parameters are presented at Baseline and Week 36. | Baseline and Week 36 | 
| Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36 | The mean values of albumin and transferrin concentration for each participant throughout the study was estimated. Summary data of mean values of albumin and transferrin concentration at baseline and week 36 are presented. | Baseline and Week 36 | 
| Mean Values of Ferritin Concentration at Baseline and Week 36 | Mean values of ferritin concentration for each participant throughout the study was estimated. Summary data of mean values of ferritin concentration at Baseline and Week 36 are presented. | Baseline and Week 36 | 
| Mean Values of Transferrin Saturation at Baseline and Week 36 | The mean values of transferrin saturation (TS) for each participant were estimated throughout the study. Summary data of mean values of TS at Baseline and Week 36 are presented. | Baseline and Week 36 | 
| Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36 | The mean values of aspartate transaminase (AST) and alkaline phosphatase (ALP) levels in serum for each participant were estimated throughout the study. Summary data of mean values of Potassium and alkaline phosphatase level in serum at Baseline and Week 36 are presented. | Baseline and Week 36 | 
| Number of Participants With Adverse Events and Serious Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported. | Up to Week 40 | 
| Number of Participants With Abnormal Changes in ECG From Baseline to Week 40 | Twelve-lead ECG was performed. | From Baseline to Week 40 | 
| Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40 | Vital signs included blood pressure, pulse rate and body weight. | From Baseline to Week 40 |