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Pediatric Nephrology
Erschienen in: Pediatric Nephrology 10/2021

16.04.2021 | Original Article

Low-dose versus conventional-dose prednisolone for nephrotic syndrome relapses: a randomized controlled non-inferiority trial

verfasst von: Seenam Sheikh, Kirtisudha Mishra, Manish Kumar

Erschienen in: Pediatric Nephrology | Ausgabe 10/2021

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Abstract

Background

Reduction of steroid exposure in relapses of steroid-sensitive nephrotic syndrome (SSNS) is under-researched.

Methods

In this randomized controlled non-inferiority trial, 1–12-year-old children with relapse of SSNS were randomized to receive prednisolone 1 mg/kg/day (low dose) or 2 mg/kg/day (standard dose) until disease remission or day 15, whichever was earlier. Therapy was switched to 2 mg/kg/day in children in low-dose group not in remission by day 15. Primary outcome was days to remission, and secondary outcome being pattern of subsequent relapse(s) over 1 year. Estimating time to remission of 8 ± 2.5 days with standard-dose therapy, non-inferiority margin of 2 days, 90% power, and α-0.05, 60 patients were randomized.

Results

Of the 60 children (30 in each group) enrolled, 4 (one in low-dose group) failed remission by day 15. Time to remission was comparable between low-dose and standard-dose groups [9.0 ± 2.2 vs. 8.6 ± 2.2 days; mean difference (95% CI) 0.4 (− 0.79 to 1.59) days; p = 0.49], thus establishing non-inferiority of low dose. Median time to subsequent relapse was 86 (IQR 74.8, 97.2) and 150 (IQR 59.0, 240.9) days, in low- versus standard-dose groups, respectively (log rank p = 0.39). In follow-up, proportion of children having relapses, frequency of relapses, proportion with frequent relapse/steroid dependent (FR/SD), and cumulative corticosteroid dose taken were comparable between groups.

Conclusions

This study shows that time to achieve remission after treatment of a relapse with low-dose prednisolone is non-inferior to that after treatment with conventional dose in children with SSNS. The proportion of children achieving remission, further course, and pattern of relapses was comparable between both groups.

Graphical abstract

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Literatur
1.
Indian Pediatric Nephrology Group, Indian Academy of Pediatrics, Bagga A, Ali U, Banerjee S, Kanitkar M, Phadke KD, Senguttuvan P, Sethi S, Shah M (2008) Management of steroid sensitive nephrotic syndrome: revised guidelines. Indian Pediatr 45:203–214
2.
Emma F, Sesto A, Rizzoni G (2003) Long-term linear growth of children with severe steroid-responsive nephrotic syndrome. Pediatr Nephrol 18:783–788CrossRef
3.
Foster BJ, Shults J, Zemel BS, Leonard MB (2006) Risk factors for glucocorticoid-induced obesity in children with steroid-sensitive nephrotic syndrome. Pediatr Nephrol 21:973–980CrossRef
4.
Mishra OP, Basu B, Upadhyay SK, Prasad R, Schaefer F (2010) Behavioural abnormalities in children with nephrotic syndrome. Nephrol Dial Transplant 25:2537–2541CrossRef
5.
Zhao Y, Su BG, Xiao HJ, Zhang HW, Liu XY, Wang F, Ding J (2017) Clinical characteristics of glucocorticoid-induced eye adverse reactions in children with primary nephrotic syndrome. Beijing Da Xue Xue Bao 49:794–797PubMed
6.
Sinha A, Bagga A, Iyengar A, Mathew JL (2014) Is two-month initial prednisolone treatment for nephrotic syndrome inferior to longer duration therapy? Indian Pediatr 51:811–817CrossRef
7.
Teeninga N, Kist-van Holthe JE, van Rijswijk N, de Mos NI, Hop WC, Wetzels JF, van der Heijden AJ, Nauta J (2013) Extending prednisolone treatment does not reduce relapses in childhood nephrotic syndrome. J Am Soc Nephrol 24:149–159CrossRef
8.
Yoshikawa N, Nakanishi K, Sako M, Oba MS, Mori R, Ota E, Ishikura K, Hataya H, Honda M, Ito S, Shima Y, Kaito H, Nozu K, Nakamura H, Igarashi T, Ohashi Y, Iijima K, Japanese Study Group of Kidney Disease in Children (2015) A multicenter randomized trial indicates initial prednisolone treatment for childhood nephrotic syndrome for two months is not inferior to six-month treatment. Kidney Int 87:225–232CrossRef
9.
Webb NJ, Woolley RL, Lambe T, Frew E, Brettell EA, Barsoum EN, Trompeter RS, Cummins C, Wheatley K, Ives NJ (2019) Sixteen-week versus standard eight-week prednisolone therapy for childhood nephrotic syndrome: the PREDNOS RCT. Health Technol Assess 23:1–108CrossRef
10.
Hahn D, Hodson EM, Willis NS, Craig JC (2015) Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev 2015:CD001533PubMedCentral
11.
Arneil GC (1971) The nephrotic syndrome. Pediatr Clin N Am 18:547–559CrossRef
12.
(1979) Alternate-day versus intermittent prednisone in frequently relapsing nephrotic syndrome: a report of Arbeitsgemeinschaft für Pädiatrische Nephrologie. Lancet 1:401–403
13.
Raja K, Parikh A, Webb H, Hothi D (2017) Use of a low-dose prednisolone regimen to treat a relapse of steroid-sensitive nephrotic syndrome in children. Pediatr Nephrol 32:99–105CrossRef
14.
Choonara IA, Heney D, Meadow SR (1989) Low dose prednisolone in nephrotic syndrome. Arch Dis Child 64:610–611CrossRef
15.
Fujinaga S, Hirano D, Nishizaki N (2011) Early identification of steroid dependency in Japanese children with steroid-sensitive nephrotic syndrome undergoing short-term initial steroid therapy. Pediatr Nephrol 26:485–486CrossRef
16.
Kidney Disease: Improving Global Outcomes (KDIGO) Glomerulonephritis Work Group (2012) KDIGO clinical practice guideline for glomerulonephritis. Kidney Int 2:139–274CrossRef
17.
Mehls O, Hoyer PF (2011) Dosing of glucocorticosteroids in nephrotic syndrome. Pediatr Nephrol 26:2095–2098CrossRef
18.
Schijvens AM, Dorresteijn EM, Roeleveld N, Ter Heine R, van Wijk JAE, Bouts AHM, Keijzer-Veen MG, van de Kar NCAJ, van den Heuvel LPWJ, Schreuder MF (2017) REducing STEroids in Relapsing Nephrotic syndrome: the RESTERN study- protocol of a national, double-blind, randomised, placebo-controlled, non-inferiority intervention study. BMJ Open 7:e018148CrossRef
19.
(1979) Nephrotic syndrome in children: a randomized trial comparing two prednisone regimens in steroid-responsive patients who relapse early: report of the International Study of Kidney Disease in Children. J Pediatr 95:239–243
20.
Yadav M, Sinha A, Khandelwal P, Hari P, Bagga A (2019) Efficacy of low-dose daily versus alternate-day prednisolone in frequently relapsing nephrotic syndrome: an open-label randomized controlled trial. Pediatr Nephrol 34:829–835CrossRef
Metadaten
Titel
Low-dose versus conventional-dose prednisolone for nephrotic syndrome relapses: a randomized controlled non-inferiority trial
verfasst von
Seenam Sheikh
Kirtisudha Mishra
Manish Kumar
Publikationsdatum
16.04.2021
Verlag
Springer Berlin Heidelberg
Erschienen in
Pediatric Nephrology / Ausgabe 10/2021
Print ISSN: 0931-041X
Elektronische ISSN: 1432-198X
DOI
https://doi.org/10.1007/s00467-021-05048-1

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