Grams ME, Sang Y, Ballew SH, et al, for the Chronic Kidney Disease Prognosis Consortium. Predicting timing of clinical outcomes in patients with chronic kidney disease and severely decreased glomerular filtration rate. Kidney Int. 2018;93:1442–1451

Philippe Remy (1) , Vincent Audard (1) , Pierre André Natella (2) , Gaëlle Pelle (3) , Bertrand Dussol (4, 5) , Hélène Leray-Moragues (6) , Khedidja Bouachi (7) , Jacques Dantal (8) , Laurence Vrigneaud (9) , Alexandre Karras (10) , Frank Pourcine (1) , Philippe Gatault (11) , Philippe Grimbert (1) , Nawelle Ait Sahlia (1) , Anissa Moktefi (12) , Eric Daugas (13) , Claire Rigothier (14) , Sylvie Bastuji-Garin (15) , Dil Sahali (16) , Jean Claude Aldigier , Pierre Bataille (17) , Bernard Canaud (6) , Dominique Chauveau (18) , Christian Combe (19) , Gabriel Choukroun (20) , Emilie Cornec-Legall (21) , Karine Dahan (22) , Michel Delahousse (23) , Dominique Desvaux (24) , Patrice Deteix (25) , Antoine Durrbach (26) , Vincent Esnault (27) , Marie Essig (28) , Patrick Fievet (29) , Thierry Frouget (30) , Dominique Guerrot (31) , Michel Godin (32) , Annie Gontiers-Picard , Morgane Gosselin , Catherine Hanrotel-Saliou (33) , Anne-Elisabeth Heng (34) , Antoine Huart (18) , Antoine Humbert , Tomek Kofman (24) , Aurélie Hummel (35) , Philippe Lang (24) , Maurice Laville (36) , Yannick Lemeur (21) , Paolo Malvezzi (37) , Marie Matignon (24) , Rafik Mesbah (38) , Bruno Moulin (39) , Sandrine Muller , Jerome Olagne , Agathe Pardon (7) , François Provôt (40) , Guillaume Queffeulou (41) , Emmanuelle Plaisier (42) , Quentin Raimbourg (43) , Philippe Rieu (44) , Thomas Stehlé (45) , Philippe Vanhille (46) , Brad Astor , Adeera Levin (47) , Mila Tang , Ognjenka Djurdjev , Sankar Navaneethan , Stacey Jolly , Jesse Schold , Joseph Nally , Jonathan Emberson , John Townend (48) , Martin Landray , Harold Feldman , Chi-Yuan Hsu , James Lash , Lawrence Appel , Philip Kalra , James Ritchie , Raman Maharajan , Rachel Middleton , Donal O’donoghue , Markus Schneider (49) , Florian Kronenberg (50) , Barbara Bärthlein , Jamie Green , H. Lester Kirchner , Kevin Ho (51) , Angharad Marks , Corri Black , Gordon Prescott (52) , Nick Fluck , Masaaki Nakayama , Mariko Miyazaki , Tae Yamamoto , Gen Yamada , Angela Yee-Moon Wang (53) , Sharon Cheung , Sharon Wong , Jessie Chu , Henry Wu , Amit Garg , Eric Mcarthur , Danielle Nash , Varda Shalev , Gabriel Chodick , Peter J Blankestijn (54) , Jack F.M. Wetzels (55) , Arjan van Zuilen , Jan a J G van den Brand (56) , Lesley Inker , Mark Sarnak (57) , Hocine Tighiouart , Haitao Zhang (58) , Bénédicte Stengel (59) , Marie Metzger (59) , Martin Flamant (60) , Pascal Houillier (61) , Jean-Philippe Haymann (62) , Pablo Rios (63) , Nelson Mazzuchi , Liliana Gadola , Verónica Lamadrid , Laura Solá (64) , John Collins , C. Raina Elley , Timothy Kenealy , Olivier Moranne (65) , Cécile Couchoud (66) , Cécile Vigneau (30, 67) , Nigel Brunskill , Rupert Major , David Shepherd , James Medcalf , Csaba Kovesdy , Kamyar Kalantar-Zadeh (68) , Keiichi Sumida , Praveen Potukuchi , Hiddo J.L. Heerspink , Dick de Zeeuw , Barry Brenner , Juan Jesus Carrero (69) , Alessandro Gasparini , Abdul Rashid Qureshi , Carl-Gustaf Elinder , Frank L.J. Visseren , Yolanda van Der Graaf (70) , Marie Evans , Maria Stendahl , Staffan Schön , Mårten Segelmark (71) , Karl-Göran Prütz , David Naimark , Navdeep Tangri , Patrick Mark , Jamie Traynor , Colin Geddes , Peter Thomson , Alex Chang , Ron T Gansevoort (72) , Anna Köttgen , Andrew Levey , Luxia Zhang (73) , Shoshana Ballew , Jingsha Chen , Josef Coresh , Morgan Grams , Lucia Kwak , Kunihiro Matsushita , Yingying Sang , Aditya Surapaneni , Mark Woodward (74) , Kai-Uwe Eckardt (75) , Brenda Hemmelgarn , David Wheeler (76) , Wolfgang Winkelmayer , John Davis , Danielle Green , Michael Cheung , Tanya Green , Melissa Mcmahan , Miklos Z. Molnar

1 Service de néphrologie [CHU Henri Mondor]
2 Assistance Publique-Hôpitaux de Paris, Department of Pathology, Centre hospitalier universitaire Henri Mondor, F-94000 Créteil, France
3 Department of Nephrology and Transplantation, Foch Hospital,
4 Chirurgie urologique et transplantation rénale [Hôpital de la Conception - APHM]
5 C2VN - Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research
6 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
7 Service de néphrologie et transplantation
8 Institut Transplantation Urologie et Néphrologie
9 Service de Néphrologie [Valenciennes]
10 HEGP - Hôpital Européen Georges Pompidou [APHP]
11 Service de Néphrologie CHU TOURS
12 INSERM U955, équipe 21
13 UMR 1599
14 Department of Nephrology, Transplantation and Dialysis, Bordeaux
15 LIC - Laboratoire d'Investigation Clinique
16 Hôpital Henri Mondor
17 UNIL - Université de Lausanne = University of Lausanne
18 Service Médecine interne et immunopathologie clinique [CHU Toulouse]
19 CHU Bordeaux [Bordeaux]
20 Unité Médicale de Soins Intensifs
21 CHU - BREST - Nephrologie - CHRU Brest - Service de Nephrologie
22 Service de Département de Néphrologie = Service de Néphrologie et Dialyses [CHU Tenon]
23 Service de transplantation rénale
24 IMRB - Institut Mondor de Recherche Biomédicale
25 Service Néphrologie, Pôle REUNNIRH
26 U542
27 Service de néphrologie
28 Service de Néphrologie, Dialyse, Transplantations [CHU Limoges]
29 UTINAM - Univers, Transport, Interfaces, Nanostructures, Atmosphère et environnement, Molécules (UMR 6213)
30 CHU Pontchaillou [Rennes]
31 Service de Néphrologie [Rouen]
32 EnVI - Nouvelles Cibles Pharmacologiques de la Protection Endothéliale et de l'Insuffisance Cardiaque
33 Service de Néphrologie
34 UNH - Unité de Nutrition Humaine
35 CHU Necker - Enfants Malades [AP-HP]
36 Service de Néphrologie
37 Service de néphrologie, dialyse, aphérèses et transplantation
38 CH Boulogne sur Mer
39 Service de Néphrologie et Transplantation
40 CHU Saint-Antoine [AP-HP]
41 Service de Néphrologie [CHPC - Site Louis Pasteur]
42 Remodelage et Reparation du Tissu Renal
43 Service de Néphrologie [Bichat - Claude Bernard]
44 CHU Reims - Centre Hospitalier Universitaire de Reims
45 UPD5 Médecine - Université Paris Descartes - Faculté de Médecine
46 Service de médecine interne et néphrologie
47 Division of Nephrology [Vancouver, BC, Canada]
48 Aberdeen University
49 Fraunhofer SIT - Fraunhofer Institute for Secure Information Technology [Darmstadt]
50 Division of genetic epidemiology
51 Department of electronic engineering
52 Institute of Applied Health Sciences
53 Department of Medicine
54 Department of Nephrology [Utrecht, Pays-Bas]
55 Department of Nephrology [Nijmegen, The Netherlands]
56 Department of nephrology [Nimègue, Pays-Bas]
57 Tufts Medical Center
58 NUAA - Nanjing University of Aeronautics and Astronautics [Nanjing]
59 CESP - Centre de recherche en épidémiologie et santé des populations
60 Service de Physiologie [Bichat-Claude Bernard]
61 Service de Physiologie [Georges-Pompidou]
62 Des Maladies Rénales Rares aux Maladies Fréquentes, Remodelage et Réparation
63 Center for Research in Agricultural Genomics
64 Directora Division Epidemiologia [Montevideo, Uruguay]
65 Service de néphrologie
66 Agence de la biomédecine [Saint-Denis la Plaine]
67 Irset - Institut de recherche en santé, environnement et travail
68 Division of Nephrology, Department of Medicine
69 Divisions of Renal Medicine and Baxter Novum, Department of Clinical Science, Intervention and Technology
70 Julius Center for Health Sciences and Primary Care
71 Division of Drug Research/Clinical Pharmacology, Department of Medicine and Health, Faculty of Health Sciences
72 Department of Nephrology [Groningue, Pays-Bas]
73 Renal Division [Beijing, China]
74 The Georges Institute for International Health
75 Department of Nephrology and Hypertension [Erlangen, Germany]
76 BCM - Baylor College of Medicine

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.

Keywords: clinical trial; idiopathic nephrotic syndrome; mycophenolate; steroids

Domains: Life Sciences [q-bio]; Life Sciences [q-bio]; Human health and pathology

Philippe Remy, Vincent Audard, Pierre André Natella, Gaëlle Pelle, Bertrand Dussol, et al.. Grams ME, Sang Y, Ballew SH, et al, for the Chronic Kidney Disease Prognosis Consortium. Predicting timing of clinical outcomes in patients with chronic kidney disease and severely decreased glomerular filtration rate. Kidney Int. 2018;93:1442–1451. Kidney International, 2018, 94 (5), pp.1025-1026. ⟨10.1016/j.kint.2018.08.009⟩. ⟨hal-02445392⟩