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 Rémy, Vincent Audard, Pierre André Natella, Gaëlle Pelle, Bertrand Dussol, Helene Leray-Moragues, Cecile Vigneau, Khedidja Bouachi, Jacques Dantal, Laurence Vrigneaud, Alexandre Karras, Frank Pourcine, Philippe Gatault, Philippe Grimbert, Nawelle Ait Sahlia, Anissa Moktefi, Eric Daugas, Claire Rigothier, Sylvie Bastuji-Garin, Dil Sahali, MSN Trial Investigators, Jean Claude Aldigier, Pierre Bataille, Bernard Canaud, Dominique Chauveau, Christian Combe, Gabriel Choukroun, Emilie Cornec-Legall, Karine Dahan, Michel Delahousse, Dominique Desvaux, Patrice Deteix, Antoine Durrbach, Vincent Esnault, Marie Essig, Patrick Fievet, Thierry Frouget, Dominique Guerrot, Michel Godin, Annie Gontiers-Picard, Morgane Gosselin, Catherine Hanrotel-Saliou, Anne-Elisabeth Heng, Antoine Huart, Antoine Humbert, Tomek Kofman, Aurélie Hummel, Philippe Lang, Maurice Laville, Yannick Lemeur, Paolo Malvezzi, Marie Matignon, Rafik Mesbah, Bruno Moulin, Sandrine Muller, Jerome Olagne, Agathe Pardon, François Provot, Guillaume Queffeulou, Emmanuelle Plaisier, Quentin Raimbourg, Philippe Rieu, Thomas Stehlé, Philippe Vanhille, Philippe Rémy, Vincent Audard, Pierre André Natella, Gaëlle Pelle, Bertrand Dussol, Helene Leray-Moragues, Cecile Vigneau, Khedidja Bouachi, Jacques Dantal, Laurence Vrigneaud, Alexandre Karras, Frank Pourcine, Philippe Gatault, Philippe Grimbert, Nawelle Ait Sahlia, Anissa Moktefi, Eric Daugas, Claire Rigothier, Sylvie Bastuji-Garin, Dil Sahali, MSN Trial Investigators, Jean Claude Aldigier, Pierre Bataille, Bernard Canaud, Dominique Chauveau, Christian Combe, Gabriel Choukroun, Emilie Cornec-Legall, Karine Dahan, Michel Delahousse, Dominique Desvaux, Patrice Deteix, Antoine Durrbach, Vincent Esnault, Marie Essig, Patrick Fievet, Thierry Frouget, Dominique Guerrot, Michel Godin, Annie Gontiers-Picard, Morgane Gosselin, Catherine Hanrotel-Saliou, Anne-Elisabeth Heng, Antoine Huart, Antoine Humbert, Tomek Kofman, Aurélie Hummel, Philippe Lang, Maurice Laville, Yannick Lemeur, Paolo Malvezzi, Marie Matignon, Rafik Mesbah, Bruno Moulin, Sandrine Muller, Jerome Olagne, Agathe Pardon, François Provot, Guillaume Queffeulou, Emmanuelle Plaisier, Quentin Raimbourg, Philippe Rieu, Thomas Stehlé, Philippe Vanhille
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.
Copyright © 2018 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.
Source: PubMed