An open-label randomized controlled trial of low-dose corticosteroid plus enteric-coated mycophenolate sodium versus standard corticosteroid treatment for minimal change nephrotic syndrome in adults (MSN Study)
NATELLA, Pierre André
Assistance Publique-Hôpitaux de Paris, Department of Pathology, Centre hospitalier universitaire Henri Mondor, F-94000 Créteil, France
Clinical Epidemiology and Ageing : Geriatrie Soins Primaires et Santé Publique [CEpiA]
Voir plus >
Assistance Publique-Hôpitaux de Paris, Department of Pathology, Centre hospitalier universitaire Henri Mondor, F-94000 Créteil, France
Clinical Epidemiology and Ageing : Geriatrie Soins Primaires et Santé Publique [CEpiA]
NATELLA, Pierre André
Assistance Publique-Hôpitaux de Paris, Department of Pathology, Centre hospitalier universitaire Henri Mondor, F-94000 Créteil, France
Clinical Epidemiology and Ageing : Geriatrie Soins Primaires et Santé Publique [CEpiA]
Assistance Publique-Hôpitaux de Paris, Department of Pathology, Centre hospitalier universitaire Henri Mondor, F-94000 Créteil, France
Clinical Epidemiology and Ageing : Geriatrie Soins Primaires et Santé Publique [CEpiA]
KARRAS, Alexandre
Hôpital Européen Georges Pompidou [APHP] [HEGP]
Service de Néphrologie et Hémodialyse [CHU HEGP]
Assistance publique - Hôpitaux de Paris (AP-HP) [AP-HP]
Hôpital Européen Georges Pompidou [APHP] [HEGP]
Service de Néphrologie et Hémodialyse [CHU HEGP]
Assistance publique - Hôpitaux de Paris (AP-HP) [AP-HP]
RIGOTHIER, Claire
Department of Nephrology, Transplantation and Dialysis, Bordeaux
Bioingénierie tissulaire [BIOTIS]
Department of Nephrology, Transplantation and Dialysis, Bordeaux
Bioingénierie tissulaire [BIOTIS]
BASTUJI-GARIN, Sylvie
Centre d'Investigation Clinique Henri Mondor [CIC Henri Mondor]
Clinical Epidemiology and Ageing : Geriatrie Soins Primaires et Santé Publique [CEpiA]
Centre d'Investigation Clinique Henri Mondor [CIC Henri Mondor]
Clinical Epidemiology and Ageing : Geriatrie Soins Primaires et Santé Publique [CEpiA]
FIEVET, Patrick
Univers, Transport, Interfaces, Nanostructures, Atmosphère et environnement, Molécules (UMR 6213) [UTINAM]
Univers, Transport, Interfaces, Nanostructures, Atmosphère et environnement, Molécules (UMR 6213) [UTINAM]
FROUGET, Thierry
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
GODIN, Michel
Nouvelles Cibles Pharmacologiques de la Protection Endothéliale et de l'Insuffisance Cardiaque [EnVI]
Nouvelles Cibles Pharmacologiques de la Protection Endothéliale et de l'Insuffisance Cardiaque [EnVI]
HUMMEL, Aurélie
Hôpital Necker - Enfants Malades [AP-HP]
Service de néphrologie adultes [CHU Necker]
Hôpital Necker - Enfants Malades [AP-HP]
Service de néphrologie adultes [CHU Necker]
LEMEUR, Yannick
CHRU Brest - Service de Nephrologie [CHU - BREST - Nephrologie]
Lymphocytes B, Autoimmunité et Immunothérapies [LBAI]
CHRU Brest - Service de Nephrologie [CHU - BREST - Nephrologie]
Lymphocytes B, Autoimmunité et Immunothérapies [LBAI]
STEHLÉ, Thomas
Université Paris Descartes - Faculté de Médecine [UPD5 Médecine]
Hôpital Necker - Enfants Malades [AP-HP]
Service Néphrologie et transplantation rénale Adultes [CHU Necker]
< Réduire
Université Paris Descartes - Faculté de Médecine [UPD5 Médecine]
Hôpital Necker - Enfants Malades [AP-HP]
Service Néphrologie et transplantation rénale Adultes [CHU Necker]
Langue
en
Article de revue
Ce document a été publié dans
Kidney International. 2018-10
Nature Publishing Group
Résumé en anglais
First-line therapy of minimal change nephrotic syndrome (MCNS) in adults is extrapolated largely from pediatric studies and consists of high-dose oral corticosteroids. We assessed whether a low corticosteroid dose combined ...Lire la suite >
First-line therapy of minimal change nephrotic syndrome (MCNS) in adults is extrapolated largely from pediatric studies and consists of high-dose oral corticosteroids. We assessed whether a low corticosteroid dose combined with mycophenolate sodium was superior to a standard oral corticosteroid regimen. We enrolled 116 adults with MCNS in an open-label randomized controlled trial involving 32 French centers. Participants randomly assigned to the test group (n=58) received low-dose prednisone (0.5 mg/kg/day, maximum 40 mg/day) plus enteric-coated mycophenolate sodium 720 mg twice daily for 24 weeks; those who did not achieve complete remission after week 8 were eligible for a second-line regimen (increase in the prednisone dose to 1 mg/kg/day with or without Cyclosporine). Participants randomly assigned to the control group (n=58) received conventional high-dose prednisone (1 mg/kg/day, maximum 80 mg/day) for 24 weeks. The primary endpoint of complete remission after four weeks of treatment was ascertained in 109 participants, with no significant difference between the test and control groups. Secondary outcomes, including remission after 8 and 24 weeks of treatment, did not differ between the two groups. During 52 weeks of follow-up, MCNS relapsed in 15 participants (23.1%) who had achieved the primary outcome. Median time to relapse was similar in the test and control groups (7.1 and 5.1 months, respectively), as was the incidence of serious adverse events. Five participants died from hemorrhage (n=2) or septic shock (n=3), including 2 participants in the test group and 3 in the control group. Thus, in adult patients, treatment with low-dose prednisone plus enteric-coated mycophenolate sodium was not superior to a standard high-dose prednisone regimen to induce complete remission of MCNS.< Réduire
Mots clés en anglais
clinical trial
idiopathic nephrotic syndrome
mycophenolate
steroids
Origine
Importé de halUnités de recherche
Publications correspondantes
Affichage des publications liées par titre, auteur, créateur et discipline
-
Fluoxetine for the Symptomatic Treatment of Multiple System Atrophy: The MSA-FLUO Trial
RASCOL, Olivier; COCHEN DE COCK, Valerie; PAVY-LE TRAON, Anne ...(Movement Disorders, 2021-04-01)Article de revue -
Direction colloque Surveillance (35 intervenants), L. Laref, M. Laref
LAREF, Michaël; LAREF, Laure; LAREF, Laure ...Communication dans un congrès