Single (375 mg/m2) vs. double dose of rituximab along with mycophenolate mofetil for children with steroid-dependent/frequently relapsing nephrotic syndrome: a multicentre open-label randomized controlled trial

被引：0

作者：

Sinha, Rajiv ^{[1
]}

Pradhan, Subal ^{[2
]}

Raut, Sumantra ^{[3
]}

Banerjee, Sushmita ^{[1
]}

Sarkar, Subhankar ^{[4
]}

Akhtar, Shakil ^{[1
]}

Dasgupta, Deblina ^{[1
]}

Poddar, Sanjukta ^{[1
]}

Mandal, Mita ^{[5
]}

Kamal, Vineet Kumar ^{[6
]}

Chaudhury, Arpita Ray ^{[3
]}

Tse, Yincent ^{[7
]}

机构：

[1] Inst Child Hlth, Div Pediat Nephrol, Kolkata, India

[2] SVPPGIP, Div Pediat Nephrol, SCB MCH, Cuttack, India

[3] North Bengal Med Coll, Dept Nephrol, Darjeeling, India

[4] All India Inst Med Sci, Dept Pediat Med, Kalyani, India

[5] All India Inst Med Sci, Dept Obstet & Gynaecol, Rishikesh, India

[6] All India Inst Med Sci, Dept Biostat, Kalyani, India

[7] Great North Childrens Hosp, Dept Paediat Immunol, Newcastle Upon Tyne, England

来源：

PEDIATRIC NEPHROLOGY | 2025年 / 40卷 / 04期

关键词：

Children; Nephrotic syndrome; Rituximab; Mycophenolate mofetil; Relapse rate; CYCLOSPORINE;

D O I：

10.1007/s00467-024-06619-8

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

Background Optimal dosing of rituximab when given with mycophenolate mofetil (MMF) for frequently relapsing nephrotic syndrome/steroid-dependent nephrotic syndrome (FRNS/SDNS) remains uncertain. Methods This was a prospective, non-inferiority, open-label randomized controlled multicentre study. Children (2-18 years old) with difficult FRNS/SDNS were randomized to group A (rituximab 375 mg/m(2) once) or group B (rituximab 375 mg/m(2) twice; 7-14 days apart) followed by continuous MMF and 3 months of tapered steroids. Primary outcome at an 18-month follow-up was time to first relapse. Secondary outcomes included post rituximab time to CD19 repopulation, sustained remission and significant adverse events (SAEs). Results Ninety-six children (median age 8.6 years; IQR 6.4 to 11.3 years, 72% male) were randomized, 48 per arm. CD19 depletion (< 1%) was achieved in both groups. Three from single dose and two from double dose arm were lost to follow-up or withdrew. After 18 months, although non-inferiority could not be demonstrated, there was no difference in primary outcome either by intention-to-treat or per-protocol analysis. The restricted mean time to first relapse was 14.5 months (95% CI 13.1-15.9) in group A and 14.8 months (95% CI 13.5-16.1) in group B (p = 0.69). Relapse rate was similar between group A (19/45; 42%) and group B (16/46; 35%) (p = 0.53, hazard ratio 0.86 (95% CI 0.46-1.6)). Secondary outcomes were also similar between the groups. Conclusions Among children with FRNS/SDNS although non-inferiority could not be demonstrated, no statistically significant difference in outcome was found between 375 and 750 mg/m(2) rituximab when accompanied with MMF.

引用

页码：995 / 1004

页数：10

共 40 条

[1] Chanchlani R., Parekh R.S., Ethnic differences in childhood nephrotic syndrome, Front Pediatr, 4, (2016)
[2] Vivarelli M., Gibson K., Sinha A., Boyer O., Childhood nephrotic syndrome, Lancet, 402, pp. 809-824, (2023)
[3] Carter S.A., Mistry S., Fitzpatrick J., Banh T., Hebert D., Langlois V., Pearl R.J., Chanchlani R., Licht C.P.B., Radhakrishnan S., Brooke J., Reddon M., Levin L., Aitken-Menezes K., Noone D., Parekh R.S., Prediction of short- and long-term outcomes in childhood nephrotic syndrome, Kidney Int Rep, 5, pp. 426-434, (2019)
[4] Ishikura K., Ikeda M., Hattori S., Yoshikawa N., Sasaki S., Iijima K., Nakanishi K., Yata N., Honda M., Effective and safe treatment with cyclosporine in nephrotic children: a prospective, randomized multicenter trial, Kidney Int, 73, pp. 1167-1173, (2008)
[5] Ishikura K., Yoshikawa N., Hattori S., Sasaki S., Iijima K., Nakanishi K., Matsuyama T., Yata N., Ando T., Honda M., Treatment with microemulsified cyclosporine in children with frequently relapsing nephrotic syndrome, Nephrol Dial Transplant, 25, pp. 3956-3962, (2010)
[6] Iijima K., Sako M., Nozu K., Rituximab for nephrotic syndrome in children, Clin Exp Nephrol, 21, pp. 193-202, (2017)
[7] Ravani P., Magnasco A., Edefonti A., Murer L., Rossi R., Ghio L., Benetti E., Scozzola F., Pasini A., Dallera N., Sica F., Belingheri M., Scolari F., Ghiggeri G.M., Short-term effects of rituximab in children with steroid- and calcineurin-dependent nephrotic syndrome: a randomized controlled trial, Clin J Am Soc Nephrol, 6, pp. 1308-1315, (2011)
[8] Iijima K., Sako M., Nozu K., Mori R., Tuchida N., Kamei K., Miura K., Aya K., Nakanishi K., Ohtomo Y., Takahashi S., Tanaka R., Kaito H., Nakamura H., Ishikura K., Ito S., Ohashi Y., Rituximab for childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome: a multicentre, double-blind, randomised, placebo-controlled trial, Lancet, 384, pp. 1273-1281, (2014)
[9] Sinha R., Agrawal N., Xue Y., Chanchlani R., Pradhan S., Raina R., Marks S.D., Use of rituximab in paediatric nephrology, Arch Dis Child, 106, pp. 1058-1065, (2021)
[10] Gao X., Wang Y., Xu Z., Deng H., Yang H., Zhong F., Systematic review and meta-analysis of rituximab for steroid-dependent or frequently relapsing nephrotic syndrome in children, Front Pediatr, 9, (2021)

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