Phase I dose escalation study to evaluate the safety and pharmacokinetic profile of tefibazumab in subjects with end-stage renal disease requiring hemodialysis

Antimicrob Agents Chemother. 2006 Oct;50(10):3499-500. doi: 10.1128/AAC.00407-06.

Abstract

Two cohorts of four subjects requiring hemodialysis received tefibazumab (10 or 20 mg/kg). The mean elimination half-life was between 17 and 18 days, the average volume of distribution was 7.3 liters, and the average clearance was 12 ml/h for both dose groups. At a dose of 20 mg/kg of body weight, plasma levels were 88 microg/ml at 21 days.

Publication types

  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adhesins, Bacterial / immunology*
  • Adult
  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal / adverse effects*
  • Antibodies, Monoclonal / pharmacokinetics*
  • Female
  • Humans
  • Kidney Failure, Chronic / therapy*
  • Male
  • Middle Aged
  • Renal Dialysis*
  • Staphylococcal Infections / therapy
  • Treatment Outcome

Substances

  • Adhesins, Bacterial
  • Antibodies, Monoclonal
  • clfB protein, Staphylococcus aureus