{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T13:07:38Z","timestamp":1791896858139,"version":"4.3.4"},"reference-count":28,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2022,10,20]],"date-time":"2022-10-20T00:00:00Z","timestamp":1666224000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,10,20]],"date-time":"2022-10-20T00:00:00Z","timestamp":1666224000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Novartis Pharma AG"},{"name":"Medizinische Fakult\u00e4t Heidelberg der Universit\u00e4t Heidelberg"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pediatr Nephrol"],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Randomized controlled trials in pediatric kidney transplantation are hampered by low incidence and prevalence of kidney failure in children. Real-World Data from patient registries could facilitate the conduct of clinical trials by substituting a control cohort. However, the emulation of a control cohort by registry data in pediatric kidney transplantation has not been investigated so far.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>In this multicenter comparative analysis, we emulated the control cohort (<jats:italic>n<\/jats:italic>\u2009=\u200954) of an RCT in pediatric kidney transplant patients (CRADLE trial; ClinicalTrials.gov NCT01544491) with data derived from the Cooperative European Paediatric Renal Transplant Initiative (CERTAIN) registry, using the same inclusion and exclusion criteria (CERTAIN cohort, <jats:italic>n<\/jats:italic>\u2009=\u2009554).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Most baseline patient and transplant characteristics were well comparable between both cohorts. At year 1 posttransplant, a composite efficacy failure end point comprising biopsy-proven acute rejection, graft loss or death (5.8%\u2009\u00b1\u20093.3% vs. 7.5%\u2009\u00b1\u20091.1%, <jats:italic>P<\/jats:italic>\u2009=\u20090.33), and kidney function (72.5\u2009\u00b1\u200924.9 vs. 77.3\u2009\u00b1\u200924.2\u00a0mL\/min\/1.73 m<jats:sup>2<\/jats:sup><jats:italic>P<\/jats:italic>\u2009=\u20090.19) did not differ significantly between CRADLE and CERTAIN. Furthermore, the incidence and severity of BPAR (5.6% vs. 7.8%), the degree of proteinuria (20.2\u2009\u00b1\u200913.9 vs. 30.6\u2009\u00b1\u200958.4\u00a0g\/mol, <jats:italic>P<\/jats:italic>\u2009=\u20090.15), and the key safety parameters such as occurrence of urinary tract infections (24.1% vs. 15.5%, <jats:italic>P<\/jats:italic>\u2009=\u20090.10) were well comparable.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>In conclusion, usage of Real-World Data from patient registries such as CERTAIN to emulate the control cohort of an RCT is feasible and could facilitate the conduct of clinical trials in pediatric kidney transplantation.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Graphical abstract<\/jats:title>\n                \n              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L.T.W. is consultant of Alexion, Chiesi. He received lecture fees from Novartis, Chiesi and a reimbursement of travel cost from Astellas. The other authors declare that they have nothing to disclose and that there is no conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}