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

Samsung Medical Center

Status and phase: Unknown; Phase 4

Conditions: PD

Treatments: Drug: Mircera

Study type: Interventional

Funder types: Other

Identifiers

NCT01807481

SMC 2011-10-131

Details and patient eligibility

About

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

Full 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

Enrollment: 101 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

Mircera Arm

Experimental group

Description:

Once Monthly Mircera

Treatment:

Drug: Mircera