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Kidney Int. 2018 Dec;94(6):1217-1226. doi: 10.1016/j.kint.2018.07.021. Epub 2018 Oct 29.

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).

Author information

1
AP-HP (Assistance Publique des Hôpitaux de Paris), Groupe Hospitalier Henri-Mondor, Department of Nephrology and Renal Transplantation, Créteil, France; UPEC (Université Paris Est Créteil), INSERM (Institut National de la Santé et de la Recherche Médicale) U955, Institut Mondor de Recherche Biomédicale (IMRB), Equipe 21, Créteil, France.
2
AP-HP, Groupe Hospitalier Henri-Mondor, Department of Public Health, Clinical Research Unit (URC Mondor), Créteil, France; UPEC, IMRB, Clinical Epidemiology and Ageing Unit (CEpiA, EA 7376), Créteil, France.
3
Department of Nephrology and Transplantation, Hôpital Foch, Suresnes, France.
4
Aix-Marseille Université, Assistance Publique-Hôpitaux de Marseille, Department of Nephrology and Transplantation, Hôpital de la Timone, Marseille, France.
5
Department of Nephrology, Hôpital de la Peyronnie, Montpellier, France.
6
Centre Hospitalier Universitaire (CHU) Pontchaillou, Department of Nephrology and Transplantation, Rennes, France.
7
Department of Nephrology and Transplantation, Hôpital Hôtel Dieu, Nantes, France.
8
Department of Nephrology, Hôpital de Valenciennes, Valenciennes, France.
9
AP-HP, Department of Nephrology and Renal Transplantation, Hôpital Européen Georges-Pompidou, Paris, France.
10
Department of Nephrology and Transplantation, Hôpital Bretonneau, Tours, France.
11
AP-HP (Assistance Publique des Hôpitaux de Paris), Groupe Hospitalier Henri-Mondor, Department of Nephrology and Renal Transplantation, Créteil, France.
12
UPEC (Université Paris Est Créteil), INSERM (Institut National de la Santé et de la Recherche Médicale) U955, Institut Mondor de Recherche Biomédicale (IMRB), Equipe 21, Créteil, France; AP-HP, Department of Pathology, Groupe Hospitalier Henri-Mondor, Créteil, France.
13
AP-HP, Department of Nephrology, Hôpital Bichat, Paris Diderot Université and INSERM U1149, Paris, France.
14
Department of Nephrology Transplantation and Dialysis, CHU de Bordeaux, France; INSERM U1026 Biotis, Bordeaux Université, Bordeaux, France.
15
AP-HP (Assistance Publique des Hôpitaux de Paris), Groupe Hospitalier Henri-Mondor, Department of Nephrology and Renal Transplantation, Créteil, France; UPEC (Université Paris Est Créteil), INSERM (Institut National de la Santé et de la Recherche Médicale) U955, Institut Mondor de Recherche Biomédicale (IMRB), Equipe 21, Créteil, France. Electronic address: dil.sahali@inserm.fr.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01197040.

KEYWORDS:

clinical trial; idiopathic nephrotic syndrome; mycophenolate; steroids

PMID:
30385039
DOI:
10.1016/j.kint.2018.07.021
[Indexed for MEDLINE]

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