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

• MabThera (Drug), also known as rituximab: MabThera 500mg/50ml I.V. infusion, single dose : 375 mg/m2
• Physiological serum (Sodium Chloride, sodium citrate) (Drug): Solution for I.V. infusion Sodium Chloride (pH 6.5), polysorbate 80, sodium citrate (10.0mg/ml)

Primary outcomes

• "Treatment failure" grouping at J12: - Loss of graft - Whether improving renal function (defined by the absence of a decrease in creatinine of at least 30% compared to the maximum serum creatinine reached at the RAH) [one year]

Sex: All, ages: 18 Years to any

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

• Yvon LEBRANCHU, Principal investigator, University Hospital, Tours