{
  "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.\n\nMethods: 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.\n\nDiscussion: 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.\n\nTrial registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12624001201561p. Prospectively registered on 1 October 2024.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Nephrology and Hypertension, Perth Children’s Hospital, Perth, Australia",
    "Division of Paediatrics, Medical School, University of Western Australia, Perth, Australia",
    "Nutrition and Health Innovation Research Institute, Edith Cowan University, Perth, Australia",
    "School of Public Health, University of Sydney, Sydney, New South Wales, Australia",
    "Department of Nephrology, Children’s Hospital at Westmead, Sydney, New South Wales, Australia",
    "Department of Nephrology, Royal Children’s Hospital, Melbourne, Victoria, Australia",
    "Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia",
    "Population Innovation, Murdoch Children’s Research Institute, Melbourne, Victoria, Australia",
    "Department of Nephrology, Queensland Children’s Hospital, Brisbane, Queensland, Australia",
    "Department of Nephrology, Women’s and Children’s Hospital, Adelaide, South Australia, Australia",
    "Department of Nephrology, Monash Children’s Hospital, Melbourne, Victoria, Australia",
    "Department of Paediatrics, Monash University, Clayton, Victoria, Australia",
    "Department of Nephrology, Starship Children’s Hospital, Auckland, New Zealand",
    "Nephrotic Syndrome Trust, Bath, England",
    "Australasian Kidney Trials Network, University of Queensland, Brisbane, Queensland, Australia",
    "Centre for Kidney Research, Children’s Hospital Westmead, Sydney, New South Wales, Australia",
    "Department of Nephrology, Nottingham Children’s Hospital, Nottingham, United Kingdom",
    "Division of Nephrology, British Columbia Children’s Hospital, Vancouver, British Columbia, Canada",
    "Department of Paediatrics, University of British Columbia, Vancouver, British Columbia, Canada",
    "Flinders Clinical Trials, Flinders University, Adelaide, South Australia, Australia",
    "College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia",
    "Leeder Centre for Health Policy Economics and Data, University of Sydney, Sydney, New South Wales, Australia"
  ],
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      "name": "Armando Teixeira-Pinto"
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  "bibtex": "https://research.draconitic.com/paper/f529dmzq7q6bw.bib",
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  "doi": "10.1016/j.ekir.2026.107115",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13733328/",
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  "pdf_url": "https://www.kireports.org/article/S2468-0249(26)03347-4/pdf",
  "pmcid": "PMC13733328",
  "pmid": "42985534",
  "published": "2026-10-02",
  "publisher": "Elsevier",
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  "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",
  "title_text": "A Randomized Controlled Trial of Two Corticosteroid Dosages for Relapsed Childhood Steroid-Sensitive Nephrotic Syndrome: The OPtimising dosE in Nephrotic Syndrome (OPEN) Trial Protocol",
  "type": "peer-reviewed",
  "updated_at": "2026-11-08T12:23:08Z",
  "url": "https://research.draconitic.com/paper/f529dmzq7q6bw",
  "venue": "Kidney International Reports",
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