PD
Conditions
Keywords
Mircera, PD, Maitenance
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 Hb during the total study period * Intrapatient Hb variability (mean within-patient standard deviation for Hb) * Frequency of Micera dose level * safety
Interventions
DRUGMircera
Once Monthly Mircera
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactDae Joong Kim
Backup ContactDae Joong Kim
Outcome results
None listed