Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation

• Status: Unknown status
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a composite "TREATMENT FAILURE"

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Tours
• Collaborator: Roche Pharma AG
• Treatments: Citric Acid; Rituximab; Sodium Citrate

Criteria

Inclusion Criteria:

• Patient adult male or female (age 18 years), kidney transplantation for less than one year (transplant from a living donor or deceased), with acute humoral rejection defined by :

• The deterioration of renal function assessed by serum creatinine increase of more than 20% compared to the best value, OR

• In the first 28 days after transplantation, no significant creatinine decrease, AND

• At least 2 of the 3 following criteria:

• tissue damage such as (a) acute tubular necrosis, (b) presence of monocytes or granulocytes in the CPT and / or glomeruli and / or capillary thrombosis, (c) intimal arteritis / fibrinoid necrosis

• C4d level of CPT and / or presence of Ig or complement in lesions of fibrinoid necrosis

• Presence of HLA antibodies directed against the donor. Patient having given his written consent to participate in the clinical trial.

Exclusion Criteria:

• Pregnant or lactating

• Women during their reproductive years without effective contraception,

• A patient with multiple organ transplants,

• Patients with clinically active infection by HCV uncontrolled

• Patients with active infection, or suspected of infection by HIV or HBV, and tuberculosis,

• Patients with heart failure class IV (NYHA) cardiac disease or uncontrolled

• Patients for whom vaccination is scheduled,

• Patient with disabilities did not allow an understanding of the requirements of the test

• Patient in safeguarding justice, guardianship or trusteeship,

• Patient with cons-indication to rituximab (known hypersensitivity to any component or murine protein)

• Patient had previously received rituximab within 3 months before inclusion

• Patient participation in another clinical trial