Status:
UNKNOWN
Phase IV Study to Evaluate the Efficacy and Safety of Mircera in PD
Lead Sponsor:
Samsung Medical Center
Conditions:
PD
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- ≥18 yr of age
- peritoneal dialysis for ≥12wk before screening and during baseline period
- weekly Kt/V ≥1.8 for PD patients
- Baseline Hb concentration between 9.0 and 12.0g/dl(mean of the monthly Hb values determined in month -2 and -1)
- stable baseline Hb concentration(defined as an absolute difference ≤2g/dl between the Hb values determined in month -2 and -1)
- continuous subcutaneous maintenance epoetin or darbepoetin therapy for at least 2 months before screening and during baseline period
- 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:
- Overt gastrointestinal bleeding or any other bleeding episode necessitating transfusion wihin 2 months before screening during baseline pereiod
- RBC transfusions within 2 months before screening or during baseline period
- nonrenal causes of anemia(e.g folic acid or vitamin B12 deficiency,hemolysis)
- acute infection or chronic, uncontrolled or symptomatic inflammatory disease(e.g rhematoid arthritis,systemic lupus erythematosus)
- C-reactive protein\>30mg/dl
- poorly controlled hypertension necessitating interruption of epotien or darbepoetin in the 6 months before screening
- platelets \> 500X109/L
- pure red cell aplasia
- chronic congestive heart failure(New Yorj Heart Association class IV)
- Myocardial infarction,severe or unstable coronary artery disease,stroke,severe liver disease within the 3months before screening or during baseline
- Life expectancy \< 12months
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2015
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01807481
Start Date
March 1 2013
End Date
August 1 2015
Last Update
June 12 2013
Active Locations (2)
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1
Samsung Medical Center
Seoul, South Korea, 135-710
2
Samsung Medical Center
Seoul, South Korea, 135-710