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Peer-reviewedCC BY 4.0Kidney International Reports

A Randomized Controlled Trial of Two Corticosteroid Dosages for Relapsed Childhood Steroid-Sensitive Nephrotic Syndrome: The OPtimising dosE in Nephrotic Syndrome (OPEN) Trial Protocol

  • Nicholas G. Larkins1,2,3
  • Hugh McCarthy4,5
  • Simon A. Carter6,7,8
  • Siah Kim4,5
  • Anna Francis9
  • Rachael Kermond10
  • Lilian Johnstone11,12
  • Chanel Prestidge13
  • Wendy Cook14
  • Dawn Sheriff1
  • Kylie-Anne Mallitt4
  • Andrea K. Viecelli15
11 more authors
  • Xin Teng1
  • Chandana Guha4,16
  • Martin Christian17
  • Susan Samuel18,19
  • Kelly Loffler20,21
  • Rupali Saikia20
  • Martin Howell4,16,22
  • Germaine Wong4,16
  • Allison Jaure4,16
  • Armando Teixeira-Pinto4,16
  • Jonathan C. Craig21
22 affiliations
  1. 1Department of Nephrology and Hypertension, Perth Children’s Hospital, Perth, Australia
  2. 2Division of Paediatrics, Medical School, University of Western Australia, Perth, Australia
  3. 3Nutrition and Health Innovation Research Institute, Edith Cowan University, Perth, Australia
  4. 4School of Public Health, University of Sydney, Sydney, New South Wales, Australia
  5. 5Department of Nephrology, Children’s Hospital at Westmead, Sydney, New South Wales, Australia
  6. 6Department of Nephrology, Royal Children’s Hospital, Melbourne, Victoria, Australia
  7. 7Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia
  8. 8Population Innovation, Murdoch Children’s Research Institute, Melbourne, Victoria, Australia
  9. 9Department of Nephrology, Queensland Children’s Hospital, Brisbane, Queensland, Australia
  10. 10Department of Nephrology, Women’s and Children’s Hospital, Adelaide, South Australia, Australia
  11. 11Department of Nephrology, Monash Children’s Hospital, Melbourne, Victoria, Australia
  12. 12Department of Paediatrics, Monash University, Clayton, Victoria, Australia
  13. 13Department of Nephrology, Starship Children’s Hospital, Auckland, New Zealand
  14. 14Nephrotic Syndrome Trust, Bath, England
  15. 15Australasian Kidney Trials Network, University of Queensland, Brisbane, Queensland, Australia
  16. 16Centre for Kidney Research, Children’s Hospital Westmead, Sydney, New South Wales, Australia
  17. 17Department of Nephrology, Nottingham Children’s Hospital, Nottingham, United Kingdom
  18. 18Division of Nephrology, British Columbia Children’s Hospital, Vancouver, British Columbia, Canada
  19. 19Department of Paediatrics, University of British Columbia, Vancouver, British Columbia, Canada
  20. 20Flinders Clinical Trials, Flinders University, Adelaide, South Australia, Australia
  21. 21College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia
  22. 22Leeder Centre for Health Policy Economics and Data, University of Sydney, Sydney, New South Wales, Australia
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Abstract

Introduction: Steroid sensitive nephrotic syndrome (SSNS) is a relapsing-remitting condition treated with repeated courses of high-intensity corticosteroids. Corticosteroid-related adverse effects cause morbidity and reduce quality of life.

Methods: The OPtimising dosE in Nephrotic syndrome (OPEN) trial is a multicenter, randomized, controlled, noninferiority trial comparing high-intensity with low-intensity corticosteroid treatment in children (aged 1–16 years) with relapsed SSNS. For induction, participants will receive prednisolone 60 mg/m2 (maximum 60 mg) or 30 mg/m2 (maximum 30 mg) daily until remission. A second randomization, conditional upon remission, allocates maintenance prednisolone 40 mg/m2 (maximum 40 mg) or 20 mg/m2 (maximum 20 mg) every other day for 4 weeks. All Australian and New Zealand tertiary pediatric nephrology centers will participate. Exclusion criteria include corticosteroid use within 14 days, familial nephrotic syndrome, or biopsy findings other than minimal change disease or focal segmental glomerulosclerosis; noncorticosteroid immunosuppression is permitted. The sample size is 330, assuming median times to remission and relapse of 9 and 100 days. The primary outcomes are time-to-remission (induction) and time-to-relapse (maintenance), analyzed as the difference in restricted mean survival time (28- and 270-day horizons) with noninferiority margins of 3 and 30 days, and power calculated assuming a true difference of zero. Randomization (1:1) will use site-stratified, variably sized permuted blocks generated by the central trial pharmacy; participants, clinicians, site pharmacies, investigators, and data analysts will be blinded.

Discussion: The OPEN trial will define the safety and efficacy of low-intensity corticosteroid treatment in relapsed SSNS. If noninferiority is demonstrated, cumulative corticosteroid exposure could be halved.

Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12624001201561p. Prospectively registered on 1 October 2024.

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Cite

BibTeXRIS
BibTeX
@article{larkins2026randomized,
  title = {{A Randomized Controlled Trial of Two Corticosteroid Dosages for Relapsed Childhood Steroid-Sensitive Nephrotic Syndrome: The OPtimising dosE in Nephrotic Syndrome (OPEN) Trial Protocol}},
  author = {Nicholas G. Larkins and Hugh McCarthy and Simon A. Carter and Siah Kim and Anna Francis and Rachael Kermond and Lilian Johnstone and Chanel Prestidge and Wendy Cook and Dawn Sheriff and Kylie-Anne Mallitt and Andrea K. Viecelli and Xin Teng and Chandana Guha and Martin Christian and Susan Samuel and Kelly Loffler and Rupali Saikia and Martin Howell and Germaine Wong and Allison Jaure and Armando Teixeira-Pinto and Jonathan C. Craig},
  journal = {Kidney International Reports},
  year = {2026},
  month = oct,
  doi = {10.1016/j.ekir.2026.107115},
  url = {https://doi.org/10.1016/j.ekir.2026.107115},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - A Randomized Controlled Trial of Two Corticosteroid Dosages for Relapsed Childhood Steroid-Sensitive Nephrotic Syndrome: The OPtimising dosE in Nephrotic Syndrome (OPEN) Trial Protocol
AU  - Nicholas G. Larkins
AU  - Hugh McCarthy
AU  - Simon A. Carter
AU  - Siah Kim
AU  - Anna Francis
AU  - Rachael Kermond
AU  - Lilian Johnstone
AU  - Chanel Prestidge
AU  - Wendy Cook
AU  - Dawn Sheriff
AU  - Kylie-Anne Mallitt
AU  - Andrea K. Viecelli
AU  - Xin Teng
AU  - Chandana Guha
AU  - Martin Christian
AU  - Susan Samuel
AU  - Kelly Loffler
AU  - Rupali Saikia
AU  - Martin Howell
AU  - Germaine Wong
AU  - Allison Jaure
AU  - Armando Teixeira-Pinto
AU  - Jonathan C. Craig
PY  - 2026
DA  - 2026/10/02
JO  - Kidney International Reports
DO  - 10.1016/j.ekir.2026.107115
UR  - https://doi.org/10.1016/j.ekir.2026.107115
AB  - Introduction: Steroid sensitive nephrotic syndrome (SSNS) is a relapsing-remitting condition treated with repeated courses of high-intensity corticosteroids. Corticosteroid-related adverse effects cause morbidity and reduce quality of life.  Methods: The OPtimising dosE in Nephrotic syndrome (OPEN) trial is a multicenter, randomized, controlled, noninferiority trial comparing high-intensity with low-intensity corticosteroid treatment in children (aged 1–16 years) with relapsed SSNS. For induction, participants will receive prednisolone 60 mg/m2 (maximum 60 mg) or 30 mg/m2 (maximum 30 mg) daily until remission. A second randomization, conditional upon remission, allocates maintenance prednisolone 40 mg/m2 (maximum 40 mg) or 20 mg/m2 (maximum 20 mg) every other day for 4 weeks. All Australian and New Zealand tertiary pediatric nephrology centers will participate. Exclusion criteria include corticosteroid use within 14 days, familial nephrotic syndrome, or biopsy findings other than minimal change disease or focal segmental glomerulosclerosis; noncorticosteroid immunosuppression is permitted. The sample size is 330, assuming median times to remission and relapse of 9 and 100 days. The primary outcomes are time-to-remission (induction) and time-to-relapse (maintenance), analyzed as the difference in restricted mean survival time (28- and 270-day horizons) with noninferiority margins of 3 and 30 days, and power calculated assuming a true difference of zero. Randomization (1:1) will use site-stratified, variably sized permuted blocks generated by the central trial pharmacy; participants, clinicians, site pharmacies, investigators, and data analysts will be blinded.  Discussion: The OPEN trial will define the safety and efficacy of low-intensity corticosteroid treatment in relapsed SSNS. If noninferiority is demonstrated, cumulative corticosteroid exposure could be halved.  Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12624001201561p. Prospectively registered on 1 October 2024.
SN  - 2468-0249
ER  -