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Meta-Analysis
. 2024 Aug 22;8(8):CD001533.
doi: 10.1002/14651858.CD001533.pub7.

Corticosteroid therapy for nephrotic syndrome in children

Deirdre Hahn  1 , Susan M Samuel  2 , Narelle S Willis  3   4 , Jonathan C Craig  4   5 , Elisabeth M Hodson  4
Affiliations
Meta-Analysis

Corticosteroid therapy for nephrotic syndrome in children

Deirdre Hahn et al. Cochrane Database Syst Rev. .

Abstract

Background: In nephrotic syndrome, protein leaks from the blood into the urine through the glomeruli, resulting in hypoproteinaemia and generalised oedema. While most children with nephrotic syndrome respond to corticosteroids, 80% experience a relapsing course. Corticosteroids have reduced the death rate to around 3%; however, corticosteroids have well-recognised potentially serious adverse events such as obesity, poor growth, hypertension, diabetes mellitus, osteoporosis, cataracts, glaucoma and behavioural disturbances. This is an update of a review first published in 2000 and updated in 2002, 2005, 2007, 2015 and 2020.

Objectives: The aim of this review was to assess the benefits and harms of different corticosteroid regimens in children with steroid-sensitive nephrotic syndrome (SSNS). The benefits and harms of therapy were studied in two groups of children: 1) children in their initial episode of SSNS and 2) children who experience a relapsing course of SSNS.

Search methods: We contacted the Information Specialist and searched the Cochrane Kidney and Transplant Register of Studies up to 9 July 2024 using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal, and ClinicalTrials.gov.

Selection criteria: Randomised controlled trials (RCTs) performed in children (one to 18 years) during their initial or subsequent episode of SSNS, comparing different durations, total doses or other dose strategies using any corticosteroid agent.

Data collection and analysis: Summary estimates of effects were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes and mean difference (MD) and 95% CI for continuous outcomes. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Main results: In this 2024 update, we included five new studies, resulting in 54 studies randomising 4670 children. Risk of bias methodology was often poorly performed, with only 31 studies and 28 studies respectively assessed to be at low risk for random sequence generation and allocation concealment. Ten studies were at low risk of performance bias (blinding of participants and personnel), and 12 studies were at low risk of detection bias (blinding of outcome assessment); nine of these studies were placebo-controlled RCTs. Twenty-seven studies (fewer than 50%) were at low risk for attrition bias, and 26 studies were at low risk for reporting bias (selective outcome reporting). In studies at low risk of selection bias evaluating children in their initial episode of SSNS, there is little or no difference in the number of children with frequent relapses when comparing two months of prednisone with three months or more (RR 0.96, 95% CI 0.83 to 1.10; 755 children, 5 studies; I2 = 0%; high certainty evidence) or when comparing three months with five to seven months of therapy (RR 0.99, 95% CI 0.74 to 1.33; 376 children, 3 studies; I2 = 35%; high certainty evidence). In analyses of studies at low risk of selection bias, there is little or no difference in the number of children with any relapse by 12 to 24 months when comparing two months of prednisone with three months or more (RR 0.93, 95% CI 0.81 to 1.06; 808 children; 6 studies; I2 = 47%) or when comparing three months with five to seven months of therapy (RR 0.88, 95% CI 0.70 to 1.11; 377 children, 3 studies; I2 = 53%). Little or no difference was noted in adverse events between the different treatment durations. Amongst children with relapsing SSNS, four small studies (177 children) utilising lower doses of prednisone compared with standard regimens found little or no differences between groups in the numbers with relapse (RR 1.01, 95% CI 0.85 to 1.20; I2 = 0%). A fifth study (117 children) reported little or no difference between two weeks and four weeks of alternate-day prednisone after remission with daily prednisone. A recent large, well-designed study with 271 children found that administering daily prednisone compared with alternate-day prednisone or no prednisone during viral infection did not reduce the risk of relapse. In contrast, four previous small studies in children with frequently relapsing disease had reported that daily prednisone during viral infections compared with alternate-day prednisone or no treatment reduced the risk of relapse.

Authors' conclusions: There are four well-designed studies randomising 823 children, which have demonstrated that there is no benefit of prolonging prednisone therapy beyond two to three months in the first episode of SSNS. Small studies in children with relapsing disease have identified no differences in efficacy using lower induction doses or shorter durations of prednisone therapy. Large, well-designed studies are required to confirm these findings. While previous small studies had suggested that changing from alternate-day to daily prednisone therapy at the onset of infection reduced the likelihood of relapse, a much larger and well-designed study found no reduction in the number relapsing when administering daily prednisone at the onset of infection.

Trial registration: ClinicalTrials.gov NCT02216747 NCT00308321 NCT03141970.

PubMed Disclaimer

Conflict of interest statement

  1. Deirdre Hahn: No relevant interests were disclosed

  2. Susan Samuel: No relevant interests were disclosed

  3. Narelle Willis: No relevant interests were disclosed

  4. Jonathan Craig: No relevant interests were disclosed

  5. Elisabeth Hodson: No relevant interests were disclosed

Figures

1
1
Flow diagram for 2024 review update study selection
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Forest plot of comparison: 1 Steroid therapy in first episode: ≥ 3 months versus 2 months therapy, outcome: 1.3 Number with frequent relapses by 12 to 24 months stratified by risk of bias for selection bias.
5
5
Forest plot of comparison: 2 Steroid therapy in first episode: 5 to 7 months versus 3 months, outcome: 2.3 Number with frequent relapses stratified by risk of selection bias.
6
6
Forest plot of comparison: 7 Daily prednisolone treatment during viral infections, outcome: 7.2 Number of relapses/patient.
1.1
1.1. Analysis
Comparison 1: Steroid therapy in first episode: ≥ 3 months versus 2 months, Outcome 1: Number with frequent relapses by 12 to 24 months
1.2
1.2. Analysis
Comparison 1: Steroid therapy in first episode: ≥ 3 months versus 2 months, Outcome 2: Number relapsing by 12 to 24 months
1.3
1.3. Analysis
Comparison 1: Steroid therapy in first episode: ≥ 3 months versus 2 months, Outcome 3: Number with frequent relapses by 12 to 24 months: stratified by risk of selection bias
1.4
1.4. Analysis
Comparison 1: Steroid therapy in first episode: ≥ 3 months versus 2 months, Outcome 4: Number relapsing by 12 to 24 months: stratified by risk of selection bias
1.5
1.5. Analysis
Comparison 1: Steroid therapy in first episode: ≥ 3 months versus 2 months, Outcome 5: Adverse events
2.1
2.1. Analysis
Comparison 2: Steroid therapy in first episode: 5 to 7 months versus 3 months, Outcome 1: Number with frequent relapses by 12 to 24 months
2.2
2.2. Analysis
Comparison 2: Steroid therapy in first episode: 5 to 7 months versus 3 months, Outcome 2: Number relapsing by 12 to 24 months
2.3
2.3. Analysis
Comparison 2: Steroid therapy in first episode: 5 to 7 months versus 3 months, Outcome 3: Number with frequent relapses: stratified by risk of selection bias
2.4
2.4. Analysis
Comparison 2: Steroid therapy in first episode: 5 to 7 months versus 3 months, Outcome 4: Number relapsing by 12 to 24 months: stratified by risk of selection bias
2.5
2.5. Analysis
Comparison 2: Steroid therapy in first episode: 5 to 7 months versus 3 months, Outcome 5: Adverse events
3.1
3.1. Analysis
Comparison 3: Steroid therapy in the first episode: 1 month versus 2 months, Outcome 1: Number relapsing by 6 to 12 months
3.2
3.2. Analysis
Comparison 3: Steroid therapy in the first episode: 1 month versus 2 months, Outcome 2: Number relapsing by 12 to 24 months
3.3
3.3. Analysis
Comparison 3: Steroid therapy in the first episode: 1 month versus 2 months, Outcome 3: Number with frequent relapses
4.1
4.1. Analysis
Comparison 4: Steroid therapy in the first episode: 12 months versus 5 months, Outcome 1: Number with relapse
5.1
5.1. Analysis
Comparison 5: Steroid therapy in the first episode: different total doses given over the same duration, Outcome 1: Relapse at 12 months
5.2
5.2. Analysis
Comparison 5: Steroid therapy in the first episode: different total doses given over the same duration, Outcome 2: Number with FRNS
5.3
5.3. Analysis
Comparison 5: Steroid therapy in the first episode: different total doses given over the same duration, Outcome 3: Adverse events
6.1
6.1. Analysis
Comparison 6: Steroid therapy in first episode: methylprednisone versus prednisolone, Outcome 1: Time to remission [days]
6.2
6.2. Analysis
Comparison 6: Steroid therapy in first episode: methylprednisone versus prednisolone, Outcome 2: Number with relapse
7.1
7.1. Analysis
Comparison 7: Daily prednisolone treatment during viral infections, Outcome 1: Number with relapse with infection
7.2
7.2. Analysis
Comparison 7: Daily prednisolone treatment during viral infections, Outcome 2: Number of relapses/patient
7.3
7.3. Analysis
Comparison 7: Daily prednisolone treatment during viral infections, Outcome 3: Number of relapses/patient at 2 years
8.1
8.1. Analysis
Comparison 8: Deflazacort versus prednisolone, Outcome 1: Number with remission
8.2
8.2. Analysis
Comparison 8: Deflazacort versus prednisolone, Outcome 2: Number with relapse by 9 to 12 months
9.1
9.1. Analysis
Comparison 9: Alternate‐day or daily steroid regimens versus intermittent dosing to prevent relapse, Outcome 1: Number relapsing during therapy
9.2
9.2. Analysis
Comparison 9: Alternate‐day or daily steroid regimens versus intermittent dosing to prevent relapse, Outcome 2: Number with relapses by 9 to 12 months
9.3
9.3. Analysis
Comparison 9: Alternate‐day or daily steroid regimens versus intermittent dosing to prevent relapse, Outcome 3: Mean relapse rate/patient/year
10.1
10.1. Analysis
Comparison 10: Intravenous then oral therapy versus oral therapy alone, Outcome 1: Relapse by 6 months
11.1
11.1. Analysis
Comparison 11: Single versus divided daily doses of prednisone to prevent relapse, Outcome 1: Number with relapse
11.2
11.2. Analysis
Comparison 11: Single versus divided daily doses of prednisone to prevent relapse, Outcome 2: Mean relapse rate
11.3
11.3. Analysis
Comparison 11: Single versus divided daily doses of prednisone to prevent relapse, Outcome 3: Number of days to remission
11.4
11.4. Analysis
Comparison 11: Single versus divided daily doses of prednisone to prevent relapse, Outcome 4: Number of days to remission according to age group
11.5
11.5. Analysis
Comparison 11: Single versus divided daily doses of prednisone to prevent relapse, Outcome 5: Serious adverse events
11.6
11.6. Analysis
Comparison 11: Single versus divided daily doses of prednisone to prevent relapse, Outcome 6: Cumulative steroid dose [mg/kg]
11.7
11.7. Analysis
Comparison 11: Single versus divided daily doses of prednisone to prevent relapse, Outcome 7: Number with HPA suppression
12.1
12.1. Analysis
Comparison 12: Reduced versus standard steroid doses to prevent relapse, Outcome 1: Time to remission
12.2
12.2. Analysis
Comparison 12: Reduced versus standard steroid doses to prevent relapse, Outcome 2: Number with relapse
12.3
12.3. Analysis
Comparison 12: Reduced versus standard steroid doses to prevent relapse, Outcome 3: Number with FRNS or SDNS at 12 months
12.4
12.4. Analysis
Comparison 12: Reduced versus standard steroid doses to prevent relapse, Outcome 4: Cumulative prednisone dose to achieve remission [mg/kg]
12.5
12.5. Analysis
Comparison 12: Reduced versus standard steroid doses to prevent relapse, Outcome 5: Adverse events
13.1
13.1. Analysis
Comparison 13: Daily versus alternate‐day prednisone to prevent relapse, Outcome 1: Number of relapses in 12 months [number/year]
13.2
13.2. Analysis
Comparison 13: Daily versus alternate‐day prednisone to prevent relapse, Outcome 2: Adverse events
14.1
14.1. Analysis
Comparison 14: Short (36 days) versus long (72 days) duration alternate‐day prednisone to prevent relapse, Outcome 1: Number with relapse during treatment
14.2
14.2. Analysis
Comparison 14: Short (36 days) versus long (72 days) duration alternate‐day prednisone to prevent relapse, Outcome 2: Number with relapse by 6 months
14.3
14.3. Analysis
Comparison 14: Short (36 days) versus long (72 days) duration alternate‐day prednisone to prevent relapse, Outcome 3: Adverse events
15.1
15.1. Analysis
Comparison 15: Weight‐based versus body surface area (BSA)‐based dosing of prednisolone, Outcome 1: Relapse at 6 months
15.2
15.2. Analysis
Comparison 15: Weight‐based versus body surface area (BSA)‐based dosing of prednisolone, Outcome 2: Adverse events
15.3
15.3. Analysis
Comparison 15: Weight‐based versus body surface area (BSA)‐based dosing of prednisolone, Outcome 3: Prednisone dose
16.1
16.1. Analysis
Comparison 16: Prolonged steroid therapy (7 months) for relapsing nephrotic syndrome, Outcome 1: Number with relapses
16.2
16.2. Analysis
Comparison 16: Prolonged steroid therapy (7 months) for relapsing nephrotic syndrome, Outcome 2: Relapse rate/patient/year
16.3
16.3. Analysis
Comparison 16: Prolonged steroid therapy (7 months) for relapsing nephrotic syndrome, Outcome 3: Number with FRNS or SDNS
16.4
16.4. Analysis
Comparison 16: Prolonged steroid therapy (7 months) for relapsing nephrotic syndrome, Outcome 4: Cumulative steroid dose
16.5
16.5. Analysis
Comparison 16: Prolonged steroid therapy (7 months) for relapsing nephrotic syndrome, Outcome 5: Adverse events
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Update of

References

References to studies included in this review

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Broyer 1997 {published data only}
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Ekka 1997 {published data only}
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Mattoo 2000 {published data only}
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Mishra 2012 {published data only}
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Mocan 1999 {published data only}
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Moundekhel 2012 {published data only}
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Norero 1996 {published data only}
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    1. Norero C, Delucchi A, Lagos E, Rosati P. Long term evaluation of two prednisone treatments in initial idiopathic nephrotic syndrome (INS) in children. Preliminary findings [abstract no: P135]. Pediatric Nephrology 1995;9(6):C88. [CENTRAL: CN-00550669]
Paul 2014 {published data only}
    1. Paul SK, Muinuddin G, Jahan S, Begum A, Rahman MH, Hossain MM. Long versus standard initial prednisolone therapy in children with idiopathic nephrotic syndrome. Mymensingh Medical Journal: MMJ 2014;23(2):261-7. [MEDLINE: ] - PubMed
Pecoraro 2003 {published data only}
    1. Pecoraro C, Caropreso MR, Malgieri G, Ferretti A, Nuzzi F. Therapy of first episode steroid responsive nephrotic syndrome (FESRNS): a randomised controlled trial [abstract no: MP087]. Nephrology Dialysis Transplantation 2005;20(Suppl 5):v230. [CENTRAL: CN-00644161]
    1. Pecoraro C, Caropreso MR, Malgieri G, Ferretti AV, Raddi G, Piscitelli A, et al. Therapy of first episode of steroid responsive nephrotic syndrome: a randomised controlled trial [abstract no: OFC41]. Pediatric Nephrology 2004;19(9):C72. [CENTRAL: CN-00644160]
    1. Pecoraro C, Caropreso MR, Passaro G, Ferretti AV, Malgieri G. Therapy of first episode of steroid responsive nephrotic syndrome: a randomised controlled trial [abstract no: M199]. Nephrology Dialysis Transplantation 2003;18(Suppl 4):63. [CENTRAL: CN-00447140]
PREDNOS 2019 {published data only}2010‐022489‐2916645249
    1. Webb N, Trompeter R, Cummins C, Wheatley K, Frew E. Long-term tapering versus standard prednisolone (steroid) therapy for the treatment of the initial episode of childhood nephrotic syndrome: national multicentre randomised double blind trial [protocol]. PREDNOS Clinical Trial Protocol Version 2.1 2013 Sep 1.
    1. Webb N, Wooley R, Brettell E, Cummins C, Trompeter R, Barsoum E, et al. Standard vs extended course prednisolone therapy for the presenting episode of steroid sensitive nephrotic syndrome: the PREDNOS study [abstract no: O-08]. Pediatric Nephrology 2017;32(9):1647-8. [EMBASE: 618119435]
    1. Webb NJ, Woolley RL, Lambe T, Frew E, Brettell EA, Barsoum EN, et al. Long term tapering versus standard prednisolone treatment for first episode of childhood nephrotic syndrome: phase III randomised controlled trial and economic evaluation. BMJ 2019;365:1800. [MEDLINE: ] - PMC - PubMed
    1. Webb NJ, Woolley RL, Lambe T, Frew E, Brettell EA, Barsoum EN, et al. Sixteen-week versus standard eight-week prednisolone therapy for childhood nephrotic syndrome: the PREDNOS RCT. Health Technology Assessment (Winchester, England) 2019;23(26):1-108. [MEDLINE: ] - PMC - PubMed
PREDNOS 2 2022 {published data only}2012‐003476‐3910900733
    1. Christian M, Webb N, Mehta S, Nafsika A, Woolley R, Frew, et al. Short course daily low-dose prednisolone at the time of upper respiratory tract infection (URTI) in non-selected children with relapsing steroid sensitive nephrotic syndrome does not prevent URTI-related relapse: The PREDNOS 2 trial [abstract no: FC132]. Nephrology Dialysis Transplantation 2021;36(Suppl 1):i90. [EMBASE: 635917789]
    1. Christian M, Webb N, Mehta S, Woolley R, Brettell E, Khan A, et al. Low-dose prednisolone at the time of an URTI does not prevent relapses in steroid sensitive nephrotic syndrome but may have a health economic benefit: the PREDNOS 2 trial [abstract no: OP-50]. Pediatric Nephrology 2021;36(10):3305.
    1. Christian MT, Webb NJ, Woolley RL, Afentou N, Mehta S, Frew E, et al. Daily low-dose prednisolone to prevent relapse of steroid-sensitive nephrotic syndrome in children with an upper respiratory tract infection: PREDNOS2 RCT. Health Technology Assessment (Winchester, England) 2022;26(3):1-94. [MEDLINE: ] - PubMed
    1. Christian MT, Webb NJA, Mehta S, Woolley RL, Afentou N, Frew E, et al. Evaluation of daily low-dose prednisolone during upper respiratory tract infection to prevent relapse in children with relapsing steroid-sensitive nephrotic syndrome: the PREDNOS 2 randomized clinical trial. JAMA Pediatrics 2022;176(3):236-43. [MEDLINE: ] - PMC - PubMed
    1. Webb NJ, Frew E, Brettell EA, Milford DV, Bockenhauer D, Saleem MA, et al. Short course daily prednisolone therapy during an upper respiratory tract infection in children with relapsing steroid-sensitive nephrotic syndrome (PREDNOS 2): protocol for a randomised controlled trial. Trials [Electronic Resource] 2014;15:147. [MEDLINE: ] - PMC - PubMed
PREDNOS PILOT 2019 {published data only}2004‐001813‐33
    1. Webb NJ, Woolley RL, Lambe T, Frew E, Brettell EA, Barsoum EN, et al. Sixteen-week versus standard eight-week prednisolone therapy for childhood nephrotic syndrome: the PREDNOS RCT. Health Technology Assessment (Winchester, England) 2019;23(26):1-108. [MEDLINE: ] - PMC - PubMed
PROPINE 2020 {published data only}2012‐004326‐16
    1. Gargiulo A, Massella L, Ruggiero B, Rava L, Ciofi Degli Atti M, Materassi M, et al. Results of the PROPINE randomized controlled study suggest tapering of prednisone treatment for relapses of steroid sensitive nephrotic syndrome is not necessary in children. Kidney International 2021;99(2):475-83. [MEDLINE: ] - PubMed
    1. Gargiulo A, Vivarelli M, Pecoraro C, Pennesi M, Pasini A, Edefonti A, et al. Short versus long courses of prednisone for the treatment of relapses of steroid sensitive nephrotic syndrome. results of the PROPINE study [abstract no: O-4]. Pediatric Nephrology 2018;33(10):1810. [EMBASE: 618119435]
Raman 2016 {published data only}2014/04/004541
    1. Raman V, Krishnamurthy S, Harichandrakumar KT. Body weight-based prednisolone versus body surface area-based prednisolone regimen for induction of remission in children with nephrotic syndrome: a randomized, open-label, equivalence clinical trial. Pediatric Nephrology 2016;31(4):595-604. [MEDLINE: ] - PubMed
Satomura 2001 {published data only}
    1. Satomura K, Yamaoka K, Shima M, Tanaka Y, Ashino N, Nakagawa K, et al. Standard vs low initial dose of prednisolone therapy for first episodes of nephrotic syndrome in children [abstract no: P238]. Pediatric Nephrology 2001;16(8):C117. [CENTRAL: CN-00447593]
Sharma 2002 {unpublished data only}
    1. Gulati S, Ahmed M, Sharma RK, Gupta A, Pokhariyal S. Comparison of abrupt withdrawal versus slow tapering regimen of prednisolone therapy in the management of first episode of steroid responsive childhood idiopathic nephrotic syndrome [abstract]. Nephrology Dialysis Transplantation 2001;16(6):A87. [CENTRAL: CN-00445595]
    1. Sharma RK, Ahmed M, Gulati S, Gupta A, Pokhariyal S. Comparison of abrupt withdrawal versus slow tapering regimen of prednisolone therapy in the management of first episode of steroid responsive childhood idiopathic nephrotic syndrome. Data on file 2002.
    1. Sharma RK, Ahmed M, Gupta A, Gulati S, Sharma AP. Comparison of abrupt withdrawal versus slow tapering regimens of prednisolone therapy in management of first episode of steroid responsive childhood idiopathic nephrotic syndrome [abstract]. Journal of the American Society of Nephrology 2000;11(Sept):97A. [CENTRAL: CN-00550434]
Sheikh 2019 {published data only}
    1. Sheikh S, Mishra K, Kumar M. Low versus conventional dose prednisolone for nephrotic syndrome relapses: randomised-controlled, non-inferiority-trial [abstract no: IPN10923-86]. Pediatric Nephrology 2019;34(10):1980. - PubMed
    1. Sheikh S, Mishra K, Kumar M. Low-dose versus conventional-dose prednisolone for nephrotic syndrome relapses: a randomized controlled non-inferiority trial. Pediatric Nephrology 2021;36(10):3143–50. [MEDLINE: ] - PubMed
Singhal 2015 {published data only}2011/12/002208
    1. Singhal R, Pandit S, Dhawan N. Deflazacort versus prednisolone: randomized controlled trial in treatment of children with idiopathic nephrotic syndrome. Iranian Journal of Pediatrics 2015;25(2):e510. [MEDLINE: ] - PMC - PubMed
Sinha 2015 {published and unpublished data}2010/091/001095
    1. Bagga A, Sinha A, Saha A, Kumar M, Afzal K, Mehta A. Randomized double blind, placebo controlled trial to compare the efficacy of 3-months versus 6-months therapy with prednisolone for the first episode of idiopathic nephrotic syndrome (CTRI/2010/091/001095) [abstract no: P139]. Pediatric Nephrology 2012;27(9):1707. [EMBASE: 71386357]
    1. Sinha A, Bagga A, Sharma S, Saha A, Kumar M, Afzal K, et al. Randomized, double blind, placebo controlled trial to compare the efficacy of 3-months versus 6-months therapy with prednisolone for the first episode of idiopathic nephritic syndrome [abstract no: O-40]. Pediatric Nephrology 2013;28(8):1361-2. [EMBASE: 71126981]
    1. Sinha A, Saha A, Kumar M, Sharma S, Afzal K, Mehta A, et al. Extending initial prednisolone treatment in a randomized control trial from 3 to 6 months did not significantly influence the course of illness in children with steroid- sensitive nephrotic syndrome. Kidney International 2015;87(1):217-24. [MEDLINE: ] - PubMed
Teeninga 2013 {published data only}27871415255
    1. Teeninga N, Guan Z, Stevens J, Kist-Van Holthe JE, Ackermans MT, Heijden AJ, et al. Population pharmacokinetics of prednisolone in relation to clinical outcome in children with nephrotic syndrome. Therapeutic Drug Monitoring 2016;38(4):534-45. [EMBASE: 610346284] - PubMed
    1. Teeninga N, Kist-Van Holthe JE, De Mos NI, Peters N, Hop WC, Heijden AJ, et al. Optimal treatment of steroid sensitive nephrotic syndrome in children: a multicenter randomised controlled trial [abstract no: 450]. Pediatric Nephrology 2010;25(9):1884. [EMBASE: 70438552]
    1. Teeninga N, Kist-Van Holthe JE, De Mos NI, Van Rijswijk-Peeters N, Hop WC, Nauta J. Optimal treatment of steroid sensitive nephrotic syndrome in children: a randomised controlled trial [abstract no: P090]. Pediatric Nephrology 2008;23(9):1619. [CENTRAL: CN-01657514]
    1. Teeninga N, Kist-Van Holthe JE, Van Ruswuk N, De Mos NI, Hop WC, Wetzels JF, et al. Effect of extended prednisolone treatment from three to six months, with equal cumulative doses, on childhood nephrotic syndrome: a nation-wide randomised controlled trial [abstract no: OP61]. Pediatric Nephrology 2012;27(9):1637-8. [EMBASE: 71386208]
    1. Teeninga N, Kist-van Holthe JE, Rijswijk N, Mos NI, Hop WC, Wetzels JF, et al. Extending prednisolone treatment does not reduce relapses in childhood nephrotic syndrome. Journal of the American Society of Nephrology 2013;24(1):149-59. [MEDLINE: ] - PMC - PubMed
Tu 2022 {published data only}
    1. Tu J, Chen CY, Geng HY, Li HR, Xia H, Lin Y, et al. Clinical assessment of moderate-dose glucocorticoid in the treatment of recurrence of primary nephrotic syndrome in children: a prospective randomized controlled trial. Zhongguo Dangdai Erke Zazhi 2022;24(5):466-71. [MEDLINE: ] - PMC - PubMed
Ueda 1988 {published data only}
    1. Ueda N, Chihara M, Kawaguchi S, Niimomi Y, Nonada T, Matsumoto J, et al. Intermittent versus long-term tapering prednisolone for initial therapy in children with idiopathic nephrotic syndrome. Journal of Pediatrics 1988;112(1):122-6. [MEDLINE: ] - PubMed
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Weerasooriya 2023 {published data only}
    1. Weerasooriya WA, Abeyagunawardena AS, Thalgahagoda RS. Single vs split dose of prednisolone in the treatment of relapses of childhood nephrotic syndrome. European Journal of Pediatrics 2023;182(4):1741‐7. [DOI: 10.1007/s00431-023-04804-9] [PMID: ] - DOI - PubMed
Yadav 2019 {published data only}2012/12/003194
    1. Yadav M, Sinha A, Hari P, Bagga A. Efficacy of low-dose daily versus alternate day prednisone in children with frequently relapsing nephrotic syndrome (FRNS): open-label randomized controlled trial (RCT) [abstract no: FP-S25-09]. Pediatric Nephrology 2016;31(10):1752. [EMBASE: 612479637] - PubMed
    1. Yadav M, Sinha A, Khandelwal P, Hari P, Bagga A. Efficacy of low-dose daily versus alternate-day prednisolone in frequently relapsing nephrotic syndrome: an open-label randomized controlled trial. Pediatric Nephrology 2019;34(5):829-35. [MEDLINE: ] - PubMed
Yoshikawa 1998 {published data only}
    1. Ito H, Yoshikawa N. Multicenter controlled trial in nephrotic syndrome in Japanese children [abstract no: S-13.5]. In: 9th Congress. International Pediatric Nephrology Association; 1992 Aug 30 - Sep 4; Jerusalem, Israel. 1992:C37. [CENTRAL: CN-00484469]
    1. Nakanishi K, Iijima K, Ishikura K, Hataya H, Nakazato H, Sasaki S, et al. Two-year outcome of the ISKDC regimen and frequent-relapsing risk in children with idiopathic nephrotic syndrome. Clinical Journal of the American Society of Nephrology: CJASN 2013;8(5):756-62. [MEDLINE: ] - PMC - PubMed
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    1. Yoshikawa N, Ito H, Takehoshi Y, Honda M, Awazu M, Iijima K, et al. Standard versus long-term prednisolone with sairei-to for initial therapy in childhood steroid-responsive nephrotic syndrome: a prospective controlled study. Nippon Jinzon Gakkai Shi [Japanese Journal of Nephrology] 1998;40(8):587-90. [MEDLINE: ] - PubMed
Yoshikawa 2015 {published and unpublished data}000000747
    1. Yoshikawa N, Nakanishi K, Oba MS, Sako M, Ohashi Y, Iijima K. Increased duration and dose of prednisolone (PSL) treatment does not reduce relapses in childhood nephrotic syndrome [abstract no: SA-PO1080]. Journal of the American Society of Nephrology 2014;24(Abstracts):3B. [CENTRAL: CN-01912375]
    1. Yoshikawa N, Nakanishi K, Sako M, Oba MS, Mori R, Ota E, et al. A multicenter randomized trial indicates initial prednisolone treatment for childhood nephrotic syndrome for two months is not inferior to six-month treatment. Kidney International 2015;87(1):225-32. [MEDLINE: ] - PMC - PubMed
Zhang 2007d {published data only}
    1. Zhang Y, Huang JP, Xiao HJ, Ding J, Yao Y, Yang JY. Prospective clinical randomized controlled trial of pulse methylprednisolone therapy in children with steroid sensitive nephrotic syndrome [abstract no: 797 (P)]. Pediatric Nephrology 2007;22(9):1609. [CENTRAL: CN-01912552]

References to studies excluded from this review

APN 2006 {published data only}
    1. Arbeitsgemeinschaft fur Padiatrische Nephrologie. Results of the nephrotic syndrome study VIII of the APN: new standard treatment versus new standard treatment plus 8 weeks cyclosporin A [abstract]. Pediatric Nephrology 1999;13:C26. [CENTRAL: CN-00636143]
    1. Hoyer PF, Brodehl J. Initial treatment of idiopathic nephrotic syndrome in children: prednisone versus prednisone plus cyclosporine A: a prospective, randomized trial. Journal of the American Society of Nephrology 2006;17(4):1151–7. [MEDLINE: ] - PubMed
    1. Hoyer PF. Results of the Nephrotic Syndrome Study VIII of the APN: new standard treatment versus new standard treatment plus 8 weeks cyclosporin A [abstract]. Journal of the American Society of Nephrology 1999;10(Program & Abstracts):104A. [CENTRAL: CN-0055522]
    1. Hoyer PF, Arbeitsgemeinschaft fur Padiatrische Nephrologie. The initial treatment of idiopathic nephrotic syndrome with prednisone and cyclosporin A: preliminary results of a therapeutic trial [abstract no: P147]. Pediatric Nephrology 1995;9(6):C91. [CENTRAL: CN-00401335]
Hou 2021 {published data only}
    1. Hou X, Xu M, Li J, Li R, Zhang J, Ju J. Study of the therapeutic effects of Chinese herbal decoction combined with glucocorticoid in treating primary nephrotic syndrome in children. Evidence-based Complementary & Alternative Medicine: eCAM 2021;2:4434504. [MEDLINE: ] - PMC - PubMed
Javidi 2021 {published data only}
    1. Javidi F, Yousefichaijan P, Dorreh F, Arjmand A, Rezagholizamenjany M. Using montelukast as an add-on treatment in nephrotic syndrome pediatrics: a randomized clinical trial study. Nephro-Urology Monthly 2021;13(4):1-4. [EMBASE: 2016084908]
Wu 2022 {published data only}
    1. Wu H, Zhang L, Liu Q, Ren B, Li J. Clinical efficacy of adjuvant treatment of primary nephrotic syndrome in pediatric patients with Chinese medicine. Journal of Healthcare Engineering 2022;2022:1516633. [MEDLINE: ] - PMC - PubMed
Xu 2020b {published data only}
    1. Xu H. Study of initial steroid treatment in young children with nephrotic syndrome. clinicaltrials.gov/show/NCT04536181 (first received 2 September 2020).
Yang 2022a {published data only}
    1. Yang G, Yang H, Cui S, Shan J. Effect of Huaiqihuang Granules combined with comprehensive nursing on children with primary nephrotic syndrome. Journal of Healthcare Engineering 2022;2022:3279503. [MEDLINE: ] - PMC - PubMed
Zhang 2014 {published data only}
    1. Zhang B, Liu T, Wang W, Zhang X, Fan S, Liu Z, et al. A prospective randomly controlled clinical trial on azithromycin therapy for induction treatment of children with nephrotic syndrome. European Journal of Pediatrics 2014;173(4):509-15. [MEDLINE: ] - PubMed
    1. Zhang BL, Liu T. A prospective clinical randomized controlled trial on azithromycin therapy in induction treatment in children with nephrotic syndrome [abstract no: O-44]. Pediatric Nephrology 2013;28(8):1364. [EMBASE: 71126985]
Zhang 2021b {published data only}
    1. Zhang Y, Wu F, Huang T, Fu T. Efficacy of triple regimen of tacrolimus combined with low-dose glucocorticoid and low-dose sirolimus in treatment of steroid-resistant nephrotic syndrome in children. Pharmaceutical Care & Research 2021;21(3):181-4. [EMBASE: 2017478751]
Zhou 2021 {published data only}
    1. Zhou G, Kong X. Study on the effect of combination of prednisone and vitamin D in the treatment of primary nephrotic syndrome in children. Journal of Healthcare Engineering 2021;2021:7932721. [MEDLINE: ] - PMC - PubMed
Zhu 2021a {published data only}
    1. Zhu H, Zhang H, Chen HD, Wu HL. Effect of intensive drug regimen on laboratory indexes and safety of children with nephrotic syndrome. Chinese Journal of Pharmaceutical Biotechnology 2021;28(3):272-4. [EMBASE: 2015848399]

References to ongoing studies

CTRI/2018/05/013634 {published data only}2018/05/013634
    1. Kalra S. A randomized controlled clinical trial to compare the efficacy of standard dose of steroids vs reduced dose in treating relapses in children with steroid sensitive nephrotic syndrome. www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=25815 (first received 3 May 2018).
CTRI/2018/05/014075 {published data only}2018/05/014075
    1. Mishra K. A comparison of two doses of prednisolone for relapses in children with steroid sensitive nephrotic syndrome: a randomized controlled non inferiority trial. www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=26036 (first received 23 May 2018).
RESTERN 2017 {published data only}2016‐002430‐765670
    1. Schijvens A, Schreuder M. Steroid treatment reduction in relapsing childhood nephrotic syndrome: a new nationwide randomized controlled trial in the Netherlands - the RESTERN study [abstract no: P-163]. Pediatric Nephrology 2017;32(9):1729. [EMBASE: 618120212]
    1. Schijvens AM, Dorresteijn EM, Roeleveld N, Ter Heine R, Wijk JA, Bouts AH, et al. REducing STEroids in Relapsing Nephrotic syndrome: the RESTERN study- protocol of a national, double-blind, randomised, placebo-controlled, non-inferiority intervention study. BMJ Open 2017;7(9):e018148. [MEDLINE: ] - PMC - PubMed
Sinha 2016 {published data only}2015/06/005939
    1. Sinha A, Gipson D, Wong C, Massengil S, Ahmad A, Hari P, et al. 6-months versus 3-months prednisolone for initial therapy of steroid sensitive nephrotic syndrome: open label RCT [abstract no: IPN11430-80]. Pediatric Nephrology 2019;34(10):2076.
    1. Sinha A, Hari P, Bagga A. Randomized controlled trial to compare efficacy of 3-months versus 6-months therapy with prednisolone for the first episode of idiopathic nephrotic syndrome in children <4-yr-old [abstract no: PO-321]. Pediatric Nephrology 2016;31(10):1867-8. [EMBASE: 612479470]

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