A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.

Study Overview
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Brief Summary
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This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 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 Two Weekly Administration of Intravenous Methoxy Polyethylene Glycol-epoetin Beta (MIRCERA) for the Treatment of Chronic Renal Anemia in Dialysis Patients Not Currently Treated With Erythropoietin-stimulating Agent (ESA).

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 8.0g/dL - 10.0g/dL); no prior erythropoietin stimulating agent (ESA) therapy. Exclusion Criteria: blood transfusion within the previous 4 weeks; 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> | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* iv 0.6 micrograms/kg every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period | The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16. | Baseline (Week 0) and Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter | Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks. | Up to Week 16 | 
| Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16 | The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10-12 g/dL) during the last 4 weeks of the TP is presented. | Week 12 to Week 16 | 
| Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16 | The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented. | Week 12 to Week 16 | 
| Number of Participants With Adverse Events, Serious Adverse Events and Deaths | An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above | Up to Week 18 | 
| Number of Participants With Abnormal Electrocardiogram | Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented. | Up to Week 16 | 
| Number of Participants With Reports of Blood Transfusions | Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons. | Up to Week 16 | 
| Number of Participants With Reports of Anti-Epoetin Antibodies | Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA. | Up to Week 16 | 
| Mean White Blood Cell Count Over Time | The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Value of Mean Corpuscular Volume Over Time | Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Hypochromic Red Blood Cells Over Time | Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Platelet Count Over Time | Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Serum Iron Over Time | Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Serum Ferritin Over Time | Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Transferrin Over Time | Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Total Iron-binding Capacity Over Time | Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Transferrin Saturation Over Time | Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Serum Albumin Over Time | Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Serum Globulin Over Time | Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Serum Creatinine Over Time | Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Blood Urea Nitrogen Over Time | Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Serum Potassium Over Time | Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Serum Sodium Over Time | Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Serum Phosphate Over Time | Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Serum Bilirubin Over Time | Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Aspartate Transaminase Over Time | Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Alanine Aminotransferase Over Time | Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 | 
| Mean Serum Alkaline Phosphatase Over Time | Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. | Baseline (Week 0), Week 4, Week 10, and Week 16 |