Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation
- Conditions
- Graft Rejection
- Interventions
- Drug: Physiological serum (Sodium Chloride, sodium citrate)Drug: MabThera
- Registration Number
- NCT01066689
- Lead Sponsor
- University Hospital, Tours
- Brief Summary
Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a composite "TREATMENT FAILURE"
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 64
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Physiological serum (Sodium Chloride, sodium citrate) Patients randomized into the arm blind B. Rituximab is allowed as additional treatment from J12, within the limit of 2 infusions of rituximab. In case of insufficient efficacy of the treatment of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn. In this case (2nd infusion effective in group A and 1st infusion effective group B), a additional consultation (CS) will be provided as part of the study 7 days after infusion. In case of insufficient efficacy of the treatment,in fairness to care for patients between the 2 treatment groups, the investigators may propose to a 3rd infusion patients in group B (2nd infusion effective for this group). To prevent patients from group A will receive a 3rd infusion of rituximab, unblinding will be applied in this case by the investigator before the administration of additional treatment with rituximab. A MabThera Patients randomized into the arm blind A. Rituximab is allowed as additional treatment from J12, within the limit of 2 infusions of rituximab. In case of insufficient efficacy of the treatment of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn. In this case (2nd infusion effective in group A and 1st infusion effective group B), a additional consultation (CS) will be provided as part of the study 7 days after infusion. In case of insufficient efficacy of the treatment,in fairness to care for patients between the 2 treatment groups, the investigators may propose to a 3rd infusion patients in group B (2nd infusion effective for this group). To prevent patients from group A will receive a 3rd infusion of rituximab, unblinding will be applied in this case by the investigator before the administration of additional treatment with rituximab.
- Primary Outcome Measures
Name Time Method "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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Hospital Bicêtre
🇫🇷Paris, Le Kremlin Bicêtre, France
Hospital Sud
🇫🇷Amiens, France
Hospital Nord
🇫🇷Saint-Etienne, Saint Priez-en-Jarez, France
Hospital Foch
🇫🇷Paris, Suresnes, France
Hospital Saint-Jacques
🇫🇷Besancon, France
Hospital Gabriel Montpied
🇫🇷Clermont-ferrand, France
Hospital Hôtel Dieu
🇫🇷Nantes, France
Hospital Milétrie Jean Bernard
🇫🇷Poitiers, France
Hospital Edouard Herriot
🇫🇷Lyon, France
Hospital Lapeyronie
🇫🇷Montpellier, France
Hospital Pasteur
🇫🇷Nice, France
Hospital Pitié-Salpêtrière
🇫🇷Paris, France
Hospital Necker
🇫🇷Paris, France
Hospital Bretonneau
🇫🇷Tours, France
Hospital Lyon Sud
🇫🇷Lyon, Pierre-Benite, France
Hospital Dupuytren
🇫🇷Limoges, France
Hospital Maison Blanche
🇫🇷Reims, France
Hospital Henri Mondor
🇫🇷Paris, Créteil, France
Hospital Pellegrin
🇫🇷Bordeaux, France
Hospital Conception
🇫🇷Marseille, France
Hospital Tenon
🇫🇷Paris, France
Hospital
🇫🇷Rennes, France
Hospital Bocage
🇫🇷Dijon, France
Hospital Saint Louis
🇫🇷Paris, France
Hospital Nancy-Brabois
🇫🇷Nancy, Vandoeuvre-les-Nancy, France
Hospital Calmette
🇫🇷Lille, France
Hospital Bois-Guillaume
🇫🇷Rouen, France
Hospital Civil
🇫🇷Strasbourg, France