{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T11:20:16Z","timestamp":1790508016310,"version":"4.1.0"},"reference-count":101,"publisher":"National Institute for Health and Care Research","issue":"26","license":[{"start":{"date-parts":[[2019,5,1]],"date-time":"2019-05-01T00:00:00Z","timestamp":1556668800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["08\/53\/31"],"award-info":[{"award-number":["08\/53\/31"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\"><jats:title>Background<\/jats:title><jats:p>The optimal corticosteroid regimen for treating the presenting episode of steroid-sensitive nephrotic syndrome (SSNS) remains uncertain. Most UK centres use an 8-week regimen, despite previous systematic reviews indicating that longer regimens reduce the risk of relapse and frequently relapsing nephrotic syndrome (FRNS).<\/jats:p><\/jats:sec><jats:sec id=\"abs1-2\"><jats:title>Objectives<\/jats:title><jats:p>The primary objective was to determine whether or not an extended 16-week course of prednisolone increases the time to first relapse. The secondary objectives were to compare the relapse rate, FRNS and steroid-dependent nephrotic syndrome (SDNS) rates, requirement for alternative immunosuppressive agents and corticosteroid-related adverse events (AEs), including adverse behaviour and costs.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-3\"><jats:title>Design<\/jats:title><jats:p>Randomised double-blind parallel-group placebo-controlled trial, including a cost-effectiveness analysis.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-4\"><jats:title>Setting<\/jats:title><jats:p>One hundred and twenty-five UK paediatric departments.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-5\"><jats:title>Participants<\/jats:title><jats:p>Two hundred and thirty-seven children presenting with a first episode of SSNS. Participants aged between 1 and 15 years were randomised (1\u2009:\u20091) according to a minimisation algorithm to ensure balance of ethnicity (South Asian, white or other) and age (\u2264\u20095 or \u2265\u20096 years).<\/jats:p><\/jats:sec><jats:sec id=\"abs1-6\"><jats:title>Interventions<\/jats:title><jats:p>The control group (<jats:italic>n<\/jats:italic>\u2009=\u2009118) received standard course (SC) prednisolone therapy: 60\u2009mg\/m<jats:sup>2<\/jats:sup>\/day of prednisolone in weeks 1\u20134, 40\u2009mg\/m<jats:sup>2<\/jats:sup>of prednisolone on alternate days in weeks 5\u20138 and matching placebo on alternate days in weeks 9\u201318 (total 2240\u2009mg\/m<jats:sup>2<\/jats:sup>). The intervention group (<jats:italic>n<\/jats:italic>\u2009=\u2009119) received extended course (EC) prednisolone therapy: 60\u2009mg\/m<jats:sup>2<\/jats:sup>\/day of prednisolone in weeks 1\u20134; started at 60\u2009mg\/m<jats:sup>2<\/jats:sup>of prednisolone on alternate days in weeks 5\u201316, tapering by 10\u2009mg\/m<jats:sup>2<\/jats:sup>every 2 weeks (total 3150\u2009mg\/m<jats:sup>2<\/jats:sup>).<\/jats:p><\/jats:sec><jats:sec id=\"abs1-7\"><jats:title>Main outcome measures<\/jats:title><jats:p>The primary outcome measure was time to first relapse [Albustix<jats:sup>\u00ae<\/jats:sup>(Siemens Healthcare Limited, Frimley, UK)-positive proteinuria +++ or greater for 3 consecutive days or the presence of generalised oedema plus +++ proteinuria]. The secondary outcome measures were relapse rate, incidence of FRNS and SDNS, other immunosuppressive therapy use, rates of serious adverse events (SAEs) and AEs and the incidence of behavioural change [using Achenbach Child Behaviour Checklist (ACBC)]. A comprehensive cost-effectiveness analysis was performed. The analysis was by intention to treat. Participants were followed for a minimum of 24 months.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-8\"><jats:title>Results<\/jats:title><jats:p>There was no significant difference in time to first relapse between the SC and EC groups (hazard ratio 0.87, 95% confidence interval 0.65 to 1.17; log-rank<jats:italic>p<\/jats:italic>\u2009=\u20090.3). There were also no differences in the incidence of FRNS (SC 50% vs. EC 53%;<jats:italic>p<\/jats:italic>\u2009=\u20090.7), SDNS (44% vs. 42%;<jats:italic>p<\/jats:italic>\u2009=\u20090.8) or requirement for other immunosuppressive therapy (56% vs. 54%;<jats:italic>p<\/jats:italic>\u2009=\u20090.8). The total prednisolone dose received following completion of study medication was 5475\u2009mg vs. 6674\u2009mg (<jats:italic>p<\/jats:italic>\u2009=\u20090.07). SAE rates were not significantly different (25% vs. 17%;<jats:italic>p<\/jats:italic>\u2009=\u20090.1) and neither were AEs, except poor behaviour (yes\/no), which was less frequent with EC treatment. There were no differences in ACBC scores. EC therapy was associated with a mean increase in generic health benefit [0.0162 additional quality-adjusted life-years (QALYs)] and cost savings (\u00a34369 vs. \u00a32696).<\/jats:p><\/jats:sec><jats:sec id=\"abs1-9\"><jats:title>Limitations<\/jats:title><jats:p>Study drug formulation may have prevented some younger children who were unable to swallow whole or crushed tablets from participating.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-10\"><jats:title>Conclusions<\/jats:title><jats:p>This trial has not shown any clinical benefit for EC prednisolone therapy in UK children. The cost-effectiveness analysis suggested that EC therapy may be cheaper, with the possibility of a small QALY benefit.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-11\"><jats:title>Future work<\/jats:title><jats:p>Studies investigating EC versus SC therapy in younger children and further cost-effectiveness analyses are warranted.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-12\"><jats:title>Trial registration<\/jats:title><jats:p>Current Controlled Trials ISRCTN16645249 and EudraCT 2010-022489-29.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-13\"><jats:title>Funding<\/jats:title><jats:p>This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in<jats:italic>Health Technology Assessment<\/jats:italic>; Vol. 23, No. 26. See the NIHR Journals Library website for further project information.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta23260","type":"journal-article","created":{"date-parts":[[2019,6,3]],"date-time":"2019-06-03T09:49:11Z","timestamp":1559555351000},"page":"1-108","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":19,"title":["Sixteen-week versus standard eight-week prednisolone therapy for childhood nephrotic syndrome: the PREDNOS RCT"],"prefix":"10.3310","volume":"23","clinical-trial-number":[{"clinical-trial-number":"isrctn16645249","registry":"10.18810\/isrctn","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8572-5446","authenticated-orcid":true,"given":"Nicholas JA","family":"Webb","sequence":"first","affiliation":[{"name":"Department of Paediatric Nephrology, University of Manchester, Manchester Academic Health Science Centre, Royal Manchester Children\u2019s Hospital, Manchester, 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