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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

Service de néphrologie et transplantation, IMRB - Institut Mondor de Recherche Biomédicale

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 de Néphrologie et Immunopathologie Clinique, Centre Hospitalier Universitaire de 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

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.

Keywords : clinical trial idiopathic nephrotic syndrome mycophenolate steroids

Document type :

Journal articles

Domain :

Life Sciences [q-bio]

Life Sciences [q-bio] / Human health and pathology

Complete list of metadata

https://hal-univ-rennes1.archives-ouvertes.fr/hal-02445392
Contributor : Cécile Vigneau Connect in order to contact the contributor
Submitted on : Monday, January 20, 2020 - 10:49:26 AM
Last modification on : Thursday, October 20, 2022 - 3:10:07 PM