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

Sponsor
University Hospital, Toulouse
Study ID
NCT00820469
Phase
PHASE4
Status
Completed

Conditions

  • Autoimmune Diseases
  • Renal Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab 375 — DRUG
    rituximab 375 mg/m2 IV weekly, during 4 weeks
  • rituximab 1000 — DRUG
    rituximab 1000 mg IV, two infusions on day 1 and day 15

Study Details

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.

Key Dates

Start date
Sep 30, 2008
Status verified
May 2017
Primary completion
Nov 30, 2009
Completion
Jan 31, 2010

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: 1
    Patients treated by rituximab
  • Experimental: 2
    Patients treated by rituximab and plasma exchange

Primary Outcome Measure

Comparison of the total AUC levels between 2 arms : patients treated by rituximab alone or patients treated by rituximab and plasma exchange [ Time Frame: Determination on the overall plasma concentration profile between the start of infusion and three months after the start of infusion ]

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