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- 01GQ7BTMP416SQ99M7WANEQ79C classification A1.
- 01GQ7BTMP416SQ99M7WANEQ79C date "2023".
- 01GQ7BTMP416SQ99M7WANEQ79C language "eng".
- 01GQ7BTMP416SQ99M7WANEQ79C type journalArticle.
- 01GQ7BTMP416SQ99M7WANEQ79C hasPart 01GR3XYVX22V8GCZ9KNR28KC2Z.pdf.
- 01GQ7BTMP416SQ99M7WANEQ79C subject "Medicine and Health Sciences".
- 01GQ7BTMP416SQ99M7WANEQ79C doi "10.1007/s00467-022-05777-x".
- 01GQ7BTMP416SQ99M7WANEQ79C issn "0931-041X".
- 01GQ7BTMP416SQ99M7WANEQ79C issn "1432-198X".
- 01GQ7BTMP416SQ99M7WANEQ79C volume "38".
- 01GQ7BTMP416SQ99M7WANEQ79C abstract "Background 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. Methods In this multicenter comparative analysis, we emulated the control cohort (n = 54) 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, n = 554). Results 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%+/- 3.3% vs. 7.5%+/- 1.1%, P = 0.33), and kidney function (72.5 +/- 24.9 vs. 77.3 +/- 24.2 mL/min/1.73 m(2) P = 0.19) 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 +/- 13.9 vs. 30.6 +/- 58.4 g/mol, P = 0.15), and the key safety parameters such as occurrence of urinary tract infections (24.1% vs. 15.5%, P = 0.10) were well comparable. Conclusions 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.".
- 01GQ7BTMP416SQ99M7WANEQ79C author F39FE6A0-CFE9-11E3-B36F-0C694B2F559A.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:05cc6a6d-5424-42e6-97c7-e8e17b322c50.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:10ab20ff-6aaa-4402-ba30-cc5bc5648507.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:16e17e6b-cf21-41c5-b0b7-ce81fe5eff19.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:25b1fb66-dc78-46e0-b7a2-d9206a4e5bbe.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:28aa23f9-6079-4311-970a-14a2af9e6ea1.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:2cb8b4c8-487c-45a0-a610-c520b86b1230.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:45d5b69f-fe0d-42c2-8e30-a46ded426d74.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:4ced6f9c-b1fa-4cb3-8a7f-14d163e1c62d.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:4ed36890-29bd-4d20-a557-30ebd444cd9f.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:5c27904a-99a0-4ec8-98f2-1917679d71ff.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:70f50c39-fe7f-4599-8c19-4897ea724277.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:71714ab1-6d92-4736-9b01-514e22aebfd7.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:74c24959-cd2e-4da4-8842-03b3e7a03cb0.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:994d09ab-b31c-44ec-87a3-51198d12b919.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:ac16ea98-76f5-4605-a1bb-2ea09aa0eab5.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:b5d9cc39-06bd-4b0d-8707-0d4b3304793b.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:bef9df97-1e77-45b8-88a1-2dbd63617315.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:c1d5cc59-b9f5-40d4-a62d-f176d6240eb5.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:d0524d8f-0a5f-466f-8594-2dabfcf6abdb.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:db63dfb2-bda9-42e5-9732-007c01293ddc.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:e457da9c-ab57-4538-8b00-905de8fa022b.
- 01GQ7BTMP416SQ99M7WANEQ79C author urn:uuid:f815541f-a634-49bb-9c4c-f8fff2d8caef.
- 01GQ7BTMP416SQ99M7WANEQ79C dateCreated "2023-01-20T10:33:12Z".
- 01GQ7BTMP416SQ99M7WANEQ79C dateModified "2024-12-12T20:13:21Z".
- 01GQ7BTMP416SQ99M7WANEQ79C name "Emulation of the control cohort of a randomized controlled trial in pediatric kidney transplantation with Real-World Data from the CERTAIN Registry".
- 01GQ7BTMP416SQ99M7WANEQ79C pagination urn:uuid:570e7f55-a151-4517-a29e-e3c21c82f908.
- 01GQ7BTMP416SQ99M7WANEQ79C sameAs LU-01GQ7BTMP416SQ99M7WANEQ79C.
- 01GQ7BTMP416SQ99M7WANEQ79C sourceOrganization urn:uuid:37e9d109-9565-4123-b4fe-e5630fb46fd0.
- 01GQ7BTMP416SQ99M7WANEQ79C sourceOrganization urn:uuid:3e78bed7-2013-40c8-8f08-8fc62e8f08fc.
- 01GQ7BTMP416SQ99M7WANEQ79C type A1.