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) - Individual Prediction and Prevention of Risks of Immunosuppressive Therapies in Transplantation Access content directly
Journal Articles Kidney International Year : 2018

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)

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).

Philippe Remy (1, 2) , Vincent Audard (1, 2) , Pierre André Natella (3, 4) , Gaëlle Pelle (5) , Bertrand Dussol (6) , Hélène Leray-Moragues (7) , Cécile Vigneau (8) , Khedidja Bouachi (9) , Jacques Dantal (10) , Laurence Vrigneaud (11) , Alexandre Karras (12, 13, 14) , Frank Pourcine (1, 2) , Philippe Gatault (15) , Philippe Grimbert (1, 2) , Nawelle Ait Sahlia (1) , Anissa Moktefi (2, 16) , Eric Daugas (17) , Claire Rigothier (18, 19) , Sylvie Bastuji-Garin (20, 4) , Dil Sahali (21, 2) , Pierre Natella , Jean Claude Aldigier , Pierre Bataille (22) , Bernard Canaud (7) , Dominique Chauveau (23) , Christian Combe (24) , Gabriel Choukroun (25, 26) , Emilie Cornec-Legall (27) , Karine Dahan (28) , Michel Delahousse (29) , Dominique Desvaux (28) , Patrice Deteix (30) , Antoine Durrbach (31) , Vincent Esnault (32) , Marie Essig (33) , Patrick Fievet (34) , Thierry Frouget (35) , Dominique Guerrot (36) , Michel Godin (37) , Annie Gontiers-Picard , Morgane Gosselin , Catherine Hanrotel-Saliou (38) , Anne-Elisabeth Heng (39) , Antoine Huart (23) , Antoine Humbert , Tomek Kofman (28) , Aurélie Hummel (40, 41) , Philippe Lang (28) , Maurice Laville (42) , Yannick Lemeur (27, 43) , Paolo Malvezzi , Marie Matignon (28) , Rafik Mesbah (44) , Bruno Moulin (45) , Sandrine Muller , Jerome Olagne , Agathe Pardon (9) , François Provôt (46) , Guillaume Queffeulou (47) , Emmanuelle Plaisier (48) , Quentin Raimbourg (49) , Philippe Rieu (50) , Thomas Stehlé (51, 40, 52) , Philippe Vanhille (53) , Samia Baloul , Amel Gouja , Cedric Viallette
1 Service de néphrologie [CHU Henri Mondor]
2 INSERM U955, équipe 21
3 Assistance Publique-Hôpitaux de Paris, Department of Pathology, Centre hospitalier universitaire Henri Mondor, F-94000 Créteil, France
4 U955 Inserm - UPEC - IMRB - CEPIA/"Clinical Epidemiology And Ageing : Geriatrics, Primary Care and Public Health" [Créteil]
5 Department of Nephrology and Transplantation, Foch Hospital,
6 Chirurgie urologique et transplantation rénale [Hôpital de la Conception - APHM]
7 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
8 Service de néphrologie [Rennes]
9 Service de néphrologie et transplantation
10 Institut Transplantation Urologie et Néphrologie
11 Centre hospitalier [Valenciennes, Nord]
12 HEGP - Hôpital Européen Georges Pompidou [APHP]
13 Service de Néphrologie et Hémodialyse [CHU HEGP]
14 AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP)
15 Service de Néphrologie CHU TOURS
16 Groupe Hospitalier Henri Mondor
17 CRI (UMR_S_1149 / ERL_8252 / U1149) - Centre de recherche sur l'Inflammation
18 Department of Nephrology, Transplantation and Dialysis, Bordeaux
19 BIOTIS - Bioingénierie tissulaire
20 CIC Henri Mondor - Centre d'Investigation Clinique Henri Mondor
21 Hôpital Henri Mondor
22 UNIL - Université de Lausanne = University of Lausanne
23 Service Médecine interne et immunopathologie clinique [CHU Toulouse]
24 CHU Bordeaux
25 Service de Néphrologie-Dialyse-Transplantation [CHU Amiens-Picardie]
26 MP3CV - Mécanismes physiopathologiques et conséquences des calcifications vasculaires - UR UPJV 7517
27 CHU - BREST - Nephrologie - CHRU Brest - Service de Nephrologie
28 IMRB - Institut Mondor de Recherche Biomédicale
29 Service de transplantation rénale
30 Service Néphrologie, Pôle REUNNIRH
31 U542
32 Service de néphrologie
33 PIST - Pharmacologie des Immunosuppresseurs et de la Transplantation
34 UTINAM - Univers, Transport, Interfaces, Nanostructures, Atmosphère et environnement, Molécules (UMR 6213)
35 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
36 Service de Néphrologie [Rouen]
37 EnVI - Nouvelles Cibles Pharmacologiques de la Protection Endothéliale et de l'Insuffisance Cardiaque
38 Service de Néphrologie
39 UNH - Unité de Nutrition Humaine
40 Hôpital Necker - Enfants Malades [AP-HP]
41 Service de néphrologie adultes [CHU Necker]
42 Service de Néphrologie
43 LBAI - Lymphocytes B, Autoimmunité et Immunothérapies
44 CH Boulogne sur Mer
45 Service de Néphrologie et Transplantation
46 CHU Saint-Antoine [AP-HP]
47 Service de Néphrologie [CHPC - Site Louis Pasteur]
48 CHU Tenon [AP-HP]
49 Service de Néphrologie [Bichat - Claude Bernard]
50 Hôpital universitaire Robert Debré [Reims]
51 UPD5 Médecine - Université Paris Descartes - Faculté de Médecine
52 Service Néphrologie et transplantation rénale Adultes [CHU Necker]
53 Service de médecine interne et néphrologie
Philippe Gatault
Pierre Natella
  • Function : Author
Jean Claude Aldigier
  • Function : Author
Christian Combe
Antoine Durrbach
Dominique Guerrot
Annie Gontiers-Picard
  • Function : Author
Morgane Gosselin
  • Function : Author
Anne-Elisabeth Heng
  • Function : Author
  • PersonId : 1203054
Antoine Humbert
  • Function : Author
Tomek Kofman
  • Function : Author
  • PersonId : 957178
Maurice Laville
  • Function : Author
  • PersonId : 942493
Paolo Malvezzi
  • Function : Author
Rafik Mesbah
  • Function : Author
Sandrine Muller
  • Function : Author
Jerome Olagne
  • Function : Author
Emmanuelle Plaisier
  • Function : Author
  • PersonId : 842296
Samia Baloul
  • Function : Author
Amel Gouja
  • Function : Author
Cedric Viallette
  • Function : Author

Abstract

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.

Dates and versions

hal-01919505 , version 1 (12-11-2018)

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Philippe Remy, Vincent Audard, Pierre André Natella, Gaëlle Pelle, Bertrand Dussol, et al.. 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). Kidney International, 2018, ⟨10.1016/j.kint.2018.07.021⟩. ⟨hal-01919505⟩
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