Clinical trial NCT01807481: Phase IV Study to Evaluate the Efficacy and Safety of Mircera in PD
Official title: A Prospective,Single-arm,Multicenter Study to Evaluate the Efficacy and Safety of Mircera in Peritoneal Patients Who Already Had Been Treated With ESA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: PD
Keywords: Mircera
PD
Maitenance
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with hemoglobin 10~12 g/dl
timeFrame: Visit 0 ~ visit 10 (10 months)
Secondary outcomes:
measure: Hemoglobin stability, Dose adjustment
timeFrame: Visit0~Visit 10 (10 Months)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Dae Joong Kim
role: PRINCIPAL_INVESTIGATOR
References: