Phase IV Study to Evaluate the Efficacy and Safety of Mircera in PD

Study Overview
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Brief Summary
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The primary objective of study is to evaluate the no of patients which maintain the Hb level between 9.0   12.0 g/dl during the evaluation period

Detailed Description
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The secondary objective of study is No of patients with mean Hb level of +/-1.0g/dl difference from the baseline Hb Incidence of RBC transfusion during the titration and evaluation periods Mean Hb during the total study period Intrapatient Hb variability (mean within-patient standard deviation for Hb) Frequency of Micera dose level safety

Official Title
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A Prospective,Single-arm,Multicenter Study to Evaluate the Efficacy and Safety of Mircera in Peritoneal Patients Who Already Had Been Treated With ESA

Conditions
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PD

Intervention / Treatment
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* Drug: Mircera


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 1.≥18 yr of age 2.peritoneal dialysis for ≥12wk before screening and during baseline period 3.weekly Kt/V ≥1.8 for PD patients 4.Baseline Hb concentration between 9.0 and 12.0g/dl(mean of the monthly Hb values determined in month -2 and -1) 5.stable baseline Hb concentration(defined as an absolute difference ≤2g/dl between the Hb values determined in month -2 and -1) 6.continuous subcutaneous maintenance epoetin or darbepoetin therapy for at least 2 months before screening and during baseline period 7.adequate iron status defined as serum ferritin ≥ 100ng/ml or transferrin saturation≥20%(mean of two values deteremined in month -2 and -1) Exclusion criteria: 1.Overt gastrointestinal bleeding or any other bleeding episode necessitating transfusion wihin 2 months before screening during baseline pereiod 2.RBC transfusions within 2 months before screening or during baseline period 3.nonrenal causes of anemia(e.g folic acid or vitamin B12 deficiency,hemolysis) 4.acute infection or chronic, uncontrolled or symptomatic inflammatory disease(e.g rhematoid arthritis,systemic lupus erythematosus) 5.C-reactive protein>30mg/dl 6.poorly controlled hypertension necessitating interruption of epotien or darbepoetin in the 6 months before screening 7.platelets > 500X109/L 8.pure red cell aplasia 9.chronic congestive heart failure(New Yorj Heart Association class IV) 10.Myocardial infarction,severe or unstable coronary artery disease,stroke,severe liver disease within the 3months before screening or during baseline 11.Life expectancy < 12months

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 Arm<br>Once Monthly Mircera | Drug: Mircera<br>* Once Monthly Mircera<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with hemoglobin 10 12 g/dl | The primary objective of this study is to evaluate the no of patients which maintain the Hb-level between 10.0 13.0 g/dL during the evaluation period | Visit 0   visit 10 (10 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin stability, Dose adjustment | Incidence of RBC transfusion during the titration and evaluation periods Mean Hb during the total study period Intrapatient Hb variability (mean within patient standard deviations for Hb) Comparison between baseline and evaluation period mean Hb level Frequency of dose adjustments Safety | Visit0 Visit 10 (10 Months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mircera, PD, Maitenance