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

CompletedPhase 3

Sponsor: University Hospital, Tours

Conditions: Humoral Rejection in Kidney Transplantation

Interventions: MabThera, Physiological serum : sodium chloride, sodium citrate

Countries: France

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (30)

Paris, Créteil, France
Grenoble, La Tronche, France
Paris, Le Kremlin Bicêtre, France
Lyon, Pierre-Benite, France
Saint-Etienne, Saint Priez-en-Jarez, France
Amiens, France
Angers, France
Besançon, France
Bordeaux, France
Brest, France
Caen, France
Clermont-Ferrand, France
Dijon, France
Lille, France
Limoges, France
Lyon, France
Marseille, France
Montpellier, France
Nantes, France
Nice, France
Paris, France
Paris, France
Paris, France
Paris, France
Poitiers, France
Reims, France
Rennes, France
Rouen, France
Strasbourg, France
Tours, France