ESPN 54th Annual Meeting

ESPN 2022


 
Mycophenolate mofetil (MMF) versus cyclophosphamide (CYC) to prevent relapse in children with steroid-dependent nephrotic syndrome (SDNS): a multicentrer, randomized, controlled trial
VERONIQUE BAUDOUIN 1 ANNIE LAHOCHE 2 ISABELLE VRILLON 3 STEPHANE DECRAMER 4 SYLVIE CLOAREC 5 GWENAELLE ROUSSEY 6 DENIS MORIN 7 PHILIPPE ECKART 8 JERôME HARAMBAT 9 TIM ULINSKI 13 CHRISTINE PIETREMENT 10 FRANÇOIS NOBILI 11 DJAMAL-DINE DJEDDI 12 CLAIRE DOSSIER 1 CORINNE ALBERTI 1 JULIEN HOGAN 1

1- ROBERT DEBRE UNIVERSITY HOSPITAL- APHP
2- CHU LILLE
3- CHRU NANCY
4- CHU TOULOUSE
5- CHU TOURS
6- CHU NANTES
7- CHU MONTPELLIER
8- CHU CAEN
9- CHU BORDEAUX
10- CHU REIMS
11- CHU BESANÇON
12- CHU AMIENS
13- TROUSSEAU HOSPITAL-APHP
 
Introduction:

Previous studies demonstrated the efficacy of CYC and MMF in preventing relapses in children with SDNS but no study to date provided a clear comparison between these two treatments. This study aim at demonstrating that MMF is superior to CYC in preventing relapses in children with SDNS.

Material and methods:

 We included 70 children (2-16 years old) with SDNS in this open-labeled, randomized, controlled trial. Patients were included during a relapse and received a standardized steroid regimen. Oral CYC was administered at 2mg/kg/d for 12 weeks (cumulative dose 168mg/kg) and MMF at 1200mg/m²/d for 18 months.

Results:

70 children were include in 15 centers: 34 patients were randomized to receive CYC and 35 to MM. Patients’ characteristics did not differ between treatment groups. There was no significant difference in relapse rates at 24 months between the CYC group (58%) and the MMF group (57%), p=0,97. There were no differences between relapsers and non-relapsers in terms of sex, disease duration and cumulative dose of steroid in the year prior to inclusion. Younger age was associated with a higher rate of relapse (75% in children <6 vs. 45% in children>6, p=0,02). Among younger children, CYC tended to be associated with a higher rate of relapse compared to MMF (86% vs. 62%, p=0,15), while no difference was found in older children. No significant differences in digestive, infectious or hematological complications were found and 4 patients (12%) in the CYC reported alopecia. 

Conclusions:

 Overall, MMF was not superior to CYC in preventing relapse in children with SDNS. Children under 6 have the highest risk of relapse and MMF may be superior to CYC in this subpopulation.