Clinical trial NCT01066689: Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation
Official title: Phase III Study of Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Graft Rejection
Keywords: kidney transplantation, acute humoral rejection, rituximab
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2010-02-10
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: "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)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Henri Mondor
state: Créteil
city: Grenoble
country: France
facility: Hospital
state: La Tronche
city: Paris
country: France
facility: Hospital Bicêtre
state: Le Kremlin Bicêtre
city: Lyon
country: France
facility: Hospital Lyon Sud
state: Pierre-Benite
city: Saint-Etienne
country: France
facility: Hospital Nord
state: Saint Priez-en-Jarez
city: Paris
country: France
facility: Hospital Foch
state: Suresnes
city: Nancy
country: France
facility: Hospital Nancy-Brabois
state: Vandoeuvre-les-Nancy
city: Amiens
country: France
facility: Hospital Sud
city: Angers
country: France
facility: Hospital
city: Besancon
country: France
facility: Hospital Saint-Jacques
city: Bordeaux
country: France
facility: Hospital Pellegrin
city: Brest
country: France
facility: Hospital
city: Caen
country: France
facility: Hospital
city: Clermont-ferrand
country: France
facility: Hospital Gabriel Montpied
city: Dijon
country: France
facility: Hospital Bocage
city: Lille
country: France
facility: Hospital Calmette
city: Limoges
country: France
facility: Hospital Dupuytren
city: Lyon
country: France
facility: Hospital Edouard Herriot
city: Marseille
country: France
facility: Hospital Conception
city: Montpellier
country: France
facility: Hospital Lapeyronie
city: Nantes
country: France
facility: Hospital Hôtel Dieu
city: Nice
country: France
facility: Hospital Pasteur
city: Paris
country: France
facility: Hospital Saint Louis
city: Paris
country: France
facility: Hospital Tenon
city: Paris
country: France
facility: Hospital Pitié-Salpêtrière
city: Paris
country: France
facility: Hospital Necker
city: Poitiers
country: France
facility: Hospital Milétrie Jean Bernard
city: Reims
country: France
facility: Hospital Maison Blanche
city: Rennes
country: France
facility: Hospital
city: Rouen
country: France
facility: Hospital Bois-Guillaume
city: Strasbourg
country: France
facility: Hospital Civil
city: Tours
country: France
facility: Hospital Bretonneau
Study officials:
affiliation: University Hospital, Tours
name: Yvon LEBRANCHU
role: PRINCIPAL_INVESTIGATOR
References: