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

NCT00820469 | Completed Phase 4

• 1 other identifier: 07 140 03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplant; Autoimmune Diseases

Keywords

Rituximab; Plasma exchange; Autoimmune diseases

Outcome Measures

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

  Determination on the overall plasma concentration profile between the start of infusion and three months after the start of infusion

Secondary Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

Patients treated by rituximab

Drug: Rituximab 375

2

EXPERIMENTAL

Patients treated by rituximab and plasma exchange

Drug: rituximab 1000

Interventions

Rituximab 375 DRUG

rituximab 375 mg/m2 IV weekly, during 4 weeks

1

rituximab 1000 DRUG

rituximab 1000 mg IV, two infusions on day 1 and day 15

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31000, France

Location

Related Publications (1)

• Puisset F, White-Koning M, Kamar N, Huart A, Haberer F, Blasco H, Le Guellec C, Lafont T, Grand A, Rostaing L, Chatelut E, Pourrat J. Population pharmacokinetics of rituximab with or without plasmapheresis in kidney patients with antibody-mediated disease. Br J Clin Pharmacol. 2013 Nov;76(5):734-40. doi: 10.1111/bcp.12098.

  PMID: 23432476 RESULT

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Jacques Pourrat, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: January 12, 2009
• Study Start: September 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: January 1, 2010
• Last Updated: May 12, 2017

Record last verified: 2017-05

Locations

FR (1)