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Year : 2019  |  Volume : 2  |  Issue : 2  |  Page : 82-87

Mycophenolate mofetil for maintenance of remission in children with steroid- and calcineurin inhibitor- dependent nephrotic syndrome: A prospective, randomized multicenter trial

1 Department of Pediatrics, Chonnam National University and Children's Hospital, Gwangju, South Korea
2 Department of Pediatrics, Hallym University Kangnam Sacred Heart Hospital, Cheongju-si, Chungcheongbuk-do, South Korea
3 National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, Chungcheongbuk-do, South Korea
4 Department of Pediatrics, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea
5 Department of Pediatrics, Yeungnam University College of Medicine, Yeungnam University Hospital, Daegu, South Korea
6 Department of Pediatrics, Jeju National University, School of Medicine, Jeju, South Korea
7 Department of Pediatrics, Jang's Women's Hospital, Yangsan, South Korea
8 Department of Pediatrics, Pusan National University Children's Hospital, Yangsan, South Korea
9 Department of Pediatrics, Seoul National University Children's Hospital; Department of Pediatrics and Kidney Research Institute, Seoul National University College of Medicine, Seoul, South Korea

Correspondence Address:
Hee Gyung Kang
Hae IlSeoul National University Children's Hospital and Seoul National University College of Medicine, 101 Daehak-Ro, Jongno-Gu, Seoul 03080
South Korea
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/AJPN.AJPN_10_19

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Background: Mycophenolate mofetil (MMF), a nonsteroidal immunosuppressive agent, has been used as a therapeutic option in various immune-mediated glomerulonephritis. However, controlled studies that examine the efficacy of MMF monotherapy in steroid- and calcineurin inhibitor (CNI)-dependent nephrotic syndrome (NS) are lacking. Aim: This study assessed the efficacy and safety of MMF monotherapy in children with steroid- and CNI-dependent NS. Methods: In this prospective, randomized, open-label, multicenter pilot study, we evaluated the efficacy and safety of MMF after CNI and corticosteroid therapy in children with steroid-dependent NS. We compared the duration and timing of sustained remission between patients managed with or without MMF and monitored for adverse effects of MMF. Statistical Analysis Used: The data were analyzed using standard statistical tests on the modified intention-to-treat population. Results: The baseline characteristics between the two groups did not differ significantly. There was neither difference in the duration of the sustained remission between patients in the MMF and control groups (4.2 ± 3.5 months vs. 3.8 ± 3.4 months, respectively; P = 0.772) nor in the proportion in sustained remission after 12 months (P = 0.936). Patients received MMF did not experience significant toxicity; chiefly, self-remitting gastrointestinal adverse events were observed. Conclusions: Therapy with MMF is safe but ineffective in influencing rates of remission in patients with NS dependent on steroids and CNIs.

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