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

• Status: Unknown status
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center

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