Humoral Rejection in Kidney Transplantation
Conditions
Keywords
kidney transplantation, acute humoral rejection, rituximab
Brief summary
Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a composite TREATMENT FAILURE
Interventions
DRUGMabThera
MabThera 500mg/50ml I.V. infusion, single dose : 375 mg/m2
DRUGPhysiological serum : sodium chloride, sodium citrate
Solution for I.V. infusion Sodium Chloride (pH 6.5), polysorbate 80, sodium citrate (10.0mg/ml)
Sponsors
Roche Pharma AG
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed