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NCT Number: NCT00820469

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Toulouse

Toulouse, 31000, France

About this study

Twenty patients will be enrolled: ten patients treated by rituximab and ten patients treated by rituximab and plasma exchange. The plasma concentration of rituximab and the efficacy of the treatment will be compared between the two groups of patients.

The enrollment in the study will not change the treatment of patients except for blood sampling.

Each patient will undergo fifteen blood samples between the start of infusion of rituximab and three months after the start of infusion. For the patients who will undergo plasma exchange, three additional blood samples will be performed at each plasma exchange (at the start, at the end and one day after the plasma exchange) and a sample of the plasma exchanged will be keep.

The plasma concentration of rituximab will be determined by ELISA method (Enzyme Linked ImmunoSorbent Assay) The pharmacokinetic analyse will consist in the determination of the Area Under the Concentration Curve (AUC) by a non compartmental approach.

The AUC levels will be compared (using the t Student test) between the two populations of patients (patients treated by rituximab, versus patients treated by rituximab and plasma exchange) The efficacy of the treatment will be evaluated by the CD19+ B Cell count.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient who should be treated by rituximab for various autoimmune diseases or humoral acute rejection of renal transplant
  • Patient older than 18 years old
  • Patient who have signed the written informed consent form

Exclusion criteria

  • Patient presenting a contra indication to rituximab (hypersensitivity, active infection, severe cardiac failure (NYHA class IV))
  • Blood sampling impossibility
  • Pregnant or breasting women

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Determination of amount rituximab eliminated during a plasma exchange

    Time frame: At each plasma exchange

  2. Evaluation of the efficacy of the treatment by CD19+B Cell count

    Time frame: 15 dyas, 1, 2, 3, 6 and 9 months after rituximab infusion

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Influence of Plasma Exchange Therapy on the Pharmacokinetics of Rituximab in Patients Treated for Autoimmune Disorders.

Acronym: PK-rituximab

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jan 12, 2009
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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