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

Phase 4

Completed

• Conditions: Renal Transplant; Autoimmune Diseases
• Interventions: Drug: Rituximab 375; Drug: rituximab 1000

• Registration Number: NCT00820469
• Lead Sponsor: University Hospital, Toulouse

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-12
• Primary Completion: 2009-11
• Study Completion: 2010-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rituximab 375	Patients treated by rituximab
2	rituximab 1000	Patients treated by rituximab and plasma exchange

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Determination of amount rituximab eliminated during a plasma exchange	At each plasma exchange
Evaluation of the efficacy of the treatment by CD19+B Cell count	15 dyas, 1, 2, 3, 6 and 9 months after rituximab infusion

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France