{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T22:52:41Z","timestamp":1783032761645,"version":"3.54.6"},"reference-count":27,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2025,12,12]],"date-time":"2025-12-12T00:00:00Z","timestamp":1765497600000},"content-version":"unspecified","delay-in-days":11,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Shanghai Municipal Health Commission Clinical Research Program","award":["202240280"],"award-info":[{"award-number":["202240280"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,11,18]]},"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Sodium-glucose cotransporter-2 inhibitors have demonstrated cardiorenal protective effects in adults with chronic kidney disease (CKD), but their efficacy and safety in paediatric CKD remain uncertain. Treatment for hereditary kidney disease in children is limited. This DAPA-PedHKD study aims to evaluate the effectiveness and safety of combining renin-angiotensin-aldosterone system inhibitors (RAASi) with dapagliflozin compare to RAASi alone in children with hereditary kidney disease accompanied by proteinuria.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      DAPA-PedHKD is a multicentre, randomised, crossover, open-label clinical trial. Patients aged 6\u201318 years with hereditary kidney disease will be eligible. All patients must have received stable RAASi therapy for at least 4 weeks, with a baseline estimated glomerular filtration rate (eGFR) of \u226560 mL\/min\/1.73 m\n                      <jats:sup>2<\/jats:sup>\n                      , and either a 24-hour urinary protein level of &gt;0.2 g or a urinary protein-to-creatinine ratio (UPCR) of &gt;0.2 mg\/mg. Participants will be randomised in a 1:1 ratio to receive either dapagliflozin in addition to standard RAASi therapy or RAASi therapy alone for 12 weeks. After a 4-week washout period with continued RAASi therapy, participants will crossover to the other treatment for another 12 weeks. Outcome assessments will be conducted at baseline and at weeks 2, 6, 12, 16, 18, 22 and 28. The primary outcome is the change in 24-hour urinary protein excretion from baseline to week 12. Secondary outcomes include changes in the UPCR, urinary albumin-to-creatinine ratio, serum albumin, eGFR, blood pressure and body weight from baseline to week 12. Neither participants nor investigators are blinded to treatment allocation, and placebo control is not used.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study has been approved by the Ethics Committee of the Children\u2019s Hospital of Fudan University and 11 local ethics committees. We will publish results in peer-reviewed journals and present at international conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial \" xlink:href=\"NCT06890143\">NCT06890143<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-109833","type":"journal-article","created":{"date-parts":[[2026,2,17]],"date-time":"2026-02-17T11:10:03Z","timestamp":1771326603000},"page":"e109833","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Effects and safety of dapagliflozin in paediatric hereditary kidney disease: protocol for a multicentric, prospective, open and randomised crossover study (DAPA-PedHKD)"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06890143","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06890143","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06890143","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05944016","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Wei","family":"Zhang","sequence":"first","affiliation":[{"name":"Department of Nephrology, Children\u2019s Hospital of Fudan University, Shanghai, China"},{"name":"Shanghai Kidney Development and Paediatric Kidney Disease Research Centre, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yalan","family":"Dou","sequence":"additional","affiliation":[{"name":"Clinical Trial Unit, Children\u2019s Hospital of Fudan University, Shanghai, 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