drugset / Trial / NCT00820469

Study of the Influence of Plasma Exchange on the Pharmacokinetics of Rituximab

NCT00820469

Phase 4 Completed 20 enrolled University Hospital, Toulouse
Non-randomizedParallel-groupOpen-labelOther

Summary

Rituximab (a monoclonal antibody raised against CD20) is used to treat various immune disorders. In some cases such as treatment of humoral acute rejection of renal transplant, thrombotic thrombocytopenic purpura, vasculitis or cryoglobulinemia, rituximab is often associated with plasma exchange. The pharmacokinetic of the rituximab can be affected by plasma exchange but the knowledge is poor in this matter. The aim of the study is to explore the influence of plasma exchange on the pharmacokinetic of rituximab. The results of this study should conclude if plasma exchange leads to a significant decrease of plasma concentration of rituximab or not, and if the decreased of the concentration is associated with a decrease in efficacy.

Timeline

Start
2008-09
Primary completion
2009-11
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 1000 mg Intravenous

Indications