Informations générales (source: ClinicalTrials.gov)
Phase III Study of Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation. (RITUX-ERAH)
Interventional
Phase 3
University Hospital, Tours (Voir sur ClinicalTrials)
octobre 2008
octobre 2011
29 juin 2024
Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based
on a composite "TREATMENT FAILURE"
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Necker-Enfants Malades | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| HOPITAL FOCH | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hospital - 14033 - Caen - France | Contact (sur clinicalTrials) | ||||
| Hospital - 49933 - Angers - France | Contact (sur clinicalTrials) | ||||
| Hospital Bocage - 21000 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Hospital Bois-Guillaume - 76231 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Hospital Bretonneau - 37044 - Tours - France | Contact (sur clinicalTrials) | ||||
| Hospital Calmette - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Hospital Civil - 67091 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Hospital Conception - 13385 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Hospital Dupuytren - 87042 - Limoges - France | Contact (sur clinicalTrials) | ||||
| Hospital Gabriel Montpied - 63003 - Clermont-ferrand - France | Contact (sur clinicalTrials) | ||||
| Hospital Hôtel Dieu - 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Hospital Lapeyronie - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Hospital Lyon Sud - 69495 - Lyon - Pierre-Benite - France | Contact (sur clinicalTrials) | ||||
| Hospital Pasteur - 06000 - Nice - France | Contact (sur clinicalTrials) | ||||
| Hospital Pellegrin - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Hospital Saint-Jacques - 25030 - Besancon - France | Contact (sur clinicalTrials) | ||||
| Hospital Sud - 80054 - Amiens - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hospital - 29609 - Brest - France | Contact (sur clinicalTrials) | ||||
| Hospital - 35033 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Hospital - 38700 - Grenoble - La Tronche - France | Contact (sur clinicalTrials) | ||||
| Hospital Bicêtre - 94275 - Paris - Le Kremlin Bicêtre - France | Contact (sur clinicalTrials) | ||||
| Hospital Edouard Herriot - 69437 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hospital Maison Blanche - 51092 - Reims - France | Contact (sur clinicalTrials) | ||||
| Hospital Milétrie Jean Bernard - 86021 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Hospital Nancy-Brabois - 54511 - Nancy - Vandoeuvre-les-Nancy - France | Contact (sur clinicalTrials) | ||||
| Hospital Nord - 42227 - Saint-Etienne - Saint Priez-en-Jarez - France | Contact (sur clinicalTrials) | ||||
| Hospital Pitié-Salpêtrière - 75651 - Paris - France | Contact (sur clinicalTrials) | ||||
| Hospital Saint Louis - 75000 - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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