Phase IV Study to Evaluate the Efficacy and Safety of Mircera in PD
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mircera Arm Once Monthly Mircera |
Drug: Mircera
Once Monthly Mircera
|
Outcome Measures
Primary Outcome Measures
- Number of patients with hemoglobin 10~12 g/dl [Visit 0 ~ visit 10 (10 months)]
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
Secondary Outcome Measures
- Hemoglobin stability, Dose adjustment [Visit0~Visit 10 (10 Months)]
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
Eligibility Criteria
Criteria
Inclusion criteria:
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1.≥18 yr of age
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2.peritoneal dialysis for ≥12wk before screening and during baseline period
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3.weekly Kt/V ≥1.8 for PD patients
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4.Baseline Hb concentration between 9.0 and 12.0g/dl(mean of the monthly Hb values determined in month -2 and -1)
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5.stable baseline Hb concentration(defined as an absolute difference ≤2g/dl between the Hb values determined in month -2 and -1)
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6.continuous subcutaneous maintenance epoetin or darbepoetin therapy for at least 2 months before screening and during baseline period
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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:
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1.Overt gastrointestinal bleeding or any other bleeding episode necessitating transfusion wihin 2 months before screening during baseline pereiod
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2.RBC transfusions within 2 months before screening or during baseline period
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3.nonrenal causes of anemia(e.g folic acid or vitamin B12 deficiency,hemolysis)
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4.acute infection or chronic, uncontrolled or symptomatic inflammatory disease(e.g rhematoid arthritis,systemic lupus erythematosus)
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5.C-reactive protein>30mg/dl
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6.poorly controlled hypertension necessitating interruption of epotien or darbepoetin in the 6 months before screening
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7.platelets > 500X109/L
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8.pure red cell aplasia
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9.chronic congestive heart failure(New Yorj Heart Association class IV)
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10.Myocardial infarction,severe or unstable coronary artery disease,stroke,severe liver disease within the 3months before screening or during baseline
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11.Life expectancy < 12months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Samsung Medical Center | Seoul | Korea, Republic of | 135-710 | |
| 2 | Samsung Medical Center | Seoul | Korea, Republic of | 135-710 |
Sponsors and Collaborators
- Samsung Medical Center
Investigators
- Principal Investigator: Dae Joong Kim, Samsung Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SMC 2011-10-131