Analysis of hemodialysed patients immune response to anti - Hepatitis B vaccination performing dialysis with an high capacity adsorbent polymethylmethacrylate membrane

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2011
INTERVENTION: Analysis of the effectiveness in practice of the use of polymethylmethacrylate membrane dialyzers as adjuvant in the treatment of dialysis patients in the course of anti ‐ Hepatitis B vaccination. Arm1: patients on maintainance thrice‐weekly dialysis resulting non responder to anti‐Hepatitis B vaccination in accordance with Center for Desease Control (CDC) and prevention criteria and discontinuing their actual dialysis membrane switching to a polymethylmethacrylate membrane with high pore size and a enhanced absorptive capacity for at least four month, at the third month receiving a regular vaccine booster dose. Arm2: patients on maintainance thrice‐weekly dialysis resulting non responder to anti‐Hepatitis B vaccine with CDC criteria not using any kind of polymetylmethacrilate membrane dialyzers, at the third month receiving a regular vaccine booster dose. We intend to observe if there is any difference between the two groups in term of response to the vaccine booster dose. CONDITION: End Stage Renal Disease patients immune system response to Hepatitis B vaccination PRIMARY OUTCOME: Efficacy of anti‐Hepatitis B vaccination in patients treated with polymethylmethacrylates membrane dialyzers. We expect a difference in the two groups of more than 25% in the number of patients with positive antibody response (Ab HBs > 10%) after the last dose of vaccine (booster). SECONDARY OUTCOME: Polymethylmethacrylate dialyzers are able decrease pre‐dialysis serum level of sCD40 (soluble form of CD40) INCLUSION CRITERIA: End Stage Renal desease patients on mainteinance thrice‐weekly dialysis treatment who had been defined as non‐responder to Hepatitis B vaccination according to CDC criteria
Epistemonikos ID: eb7650e2c0b2138f1028dc589b34b77f95a6122d
First added on: Aug 25, 2024