دورية أكاديمية
One-year Results of the Effects of Rituximab on Acute Antibody-Mediated Rejection in Renal Transplantation: RITUX ERAH, a Multicenter Double-blind Randomized Placebo-controlled Trial.
| العنوان: | One-year Results of the Effects of Rituximab on Acute Antibody-Mediated Rejection in Renal Transplantation: RITUX ERAH, a Multicenter Double-blind Randomized Placebo-controlled Trial. |
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| المؤلفون: | Sautenet, Bénédicte, Blancho, Gilles, Büchler, Mathias, Morelon, Emmanuel, Toupance, Olivier, Barrou, Benoit, Ducloux, Didier, Châtelet, Valérie, Moulin, Bruno, Freguin, Caroline, Hazzan, Marc, Lang, Philippe, Legendre, Christophe, Merville, Pierre, Mourad, Georges, Mousson, Christine, Pouteil-Noble, Claire, Purgus, Raj, Rerolle, Jean-Philippe, Sayegh, Johnny, Westeel, Pierre-François, Zaoui, Philippe, Boivin, Hedia, Le Gouge, Amélie, Lebranchu, Yvon |
| المساهمون: | Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Université Francois Rabelais Tours, Institut de transplantation urologie-néphrologie (ITUN), Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital Edouard Herriot CHU - HCL, Hospices Civils de Lyon (HCL), Hôpital Maison Blanche, Centre Hospitalier Universitaire de Reims (CHU Reims), Service d'Urologie CHU Pitié-Salpêtrière, CHU Pitié-Salpêtrière AP-HP, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Service de Néphrologie-Dialyse-Transplantation rénale CHU Caen, Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Service de néphrologie et hémodialyse CHU de Strasbourg, CHU Strasbourg, Service de Néphrologie Rouen, CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Service de Néphrologie et Transplantation rénale CHRU-lille, Centre Hospitalier Régional Universitaire Lille (CHRU Lille), Service de néphrologie et transplantation, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Service de néphrologie adultes CHU Necker, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Necker - Enfants Malades AP-HP, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Néphrologie-transplantation-dialyse Bordeaux, CHU Bordeaux Bordeaux, Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier), Aide à la Décision pour une Médecine Personnalisé - Laboratoire de Biostatistique, Epidémiologie et Recherche Clinique - EA 2415 (AIDMP), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Service de néphrologie (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre de néphrologie et transplantation rénale Hôpital de la Conception - APHM, Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception CHU - APHM (LA CONCEPTION), Service de Néphrologie, Dialyse, Transplantations CHU Limoges, CHU Limoges, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), CHU Amiens-Picardie, Service de néphrologie, dialyse, aphérèses et transplantation, CHU Grenoble-Université Grenoble Alpes 2016-2019 (UGA 2016-2019 ), Centre d’Investigation Clinique Tours CIC 1415 (CIC ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM) |
| المصدر: | ISSN: 0041-1337 ; Transplantation ; https://hal.archives-ouvertes.fr/hal-01886920Test ; Transplantation, Lippincott, Williams & Wilkins, 2016, 100 (2), pp.391 - 399. ⟨10.1097/TP.0000000000000958⟩. |
| بيانات النشر: | HAL CCSD Lippincott, Williams & Wilkins |
| سنة النشر: | 2016 |
| المجموعة: | Archive ouverte HAL (Hyper Article en Ligne, CCSD - Centre pour la Communication Scientifique Directe) |
| مصطلحات موضوعية: | [SDV.IMM]Life Sciences [q-bio]/Immunology, [SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery |
| الوصف: | International audience ; BACKGROUND:Treatment of acute antibody-mediated rejection (AMR) is based on a combination of plasma exchange (PE), IVIg, corticosteroids (CS), and rituximab, but the place of rituximab is not clearly specified in the absence of randomized trials.METHODS:In this phase III, multicenter, double-blind, placebo-controlled trial, we randomly assigned patients with biopsy-proven AMR to receive rituximab (375 mg/m) or placebo at day 5. All patients received PE, IVIg, and CS. The primary endpoint was a composite of graft loss or no improvement in renal function at day 12.RESULTS:Among the 38 patients included, at 1 year, no deaths occurred, but 1 graft loss occurred in each group. The primary endpoint frequency was 52.6% (10/19) and 57.9% (11/19) in the rituximab and placebo groups, respectively (P = 0.744). Renal function improved in both groups, as soon as day 12 with no difference in serum creatinine level and proteinuria at 1, 3, 6, and 12 months. Supplementary administration of rituximab and total number of IVIg and PE treatments did not differ between the 2 groups. Both groups showed improved histological features of AMR and Banff scores at 1 and 6 months, with no significant difference between groups but with a trend in favor of the rituximab group. Both groups showed decreased mean fluorescence intensity of donor-specific antibodies as soon as day 12, with no significant difference between them but with a trend in favor of the rituximab group at 12 months.CONCLUSIONS:After 1 year of follow-up, we observed no additional effect of rituximab in patients receiving PE, IVIg, and CS for AMR. Nevertheless, our study was underpowered and important differences between groups may have been missed. Complementary trials with long-term follow-up are needed. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/26555944; hal-01886920; https://hal.archives-ouvertes.fr/hal-01886920Test; PUBMED: 26555944 |
| DOI: | 10.1097/TP.0000000000000958 |
| الإتاحة: | https://doi.org/10.1097/TP.0000000000000958Test https://hal.archives-ouvertes.fr/hal-01886920Test |
| رقم الانضمام: | edsbas.AB1D0BA7 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1097/TP.0000000000000958 |
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