{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T12:29:24Z","timestamp":1753878564042,"version":"3.41.2"},"reference-count":31,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2017,7,28]],"date-time":"2017-07-28T00:00:00Z","timestamp":1501200000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100003593","name":"Conselho Nacional de Desenvolvimento Cient\u00edfico e Tecnol\u00f3gico","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003593","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Transplantation"],"published-print":{"date-parts":[[2017,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>The risks and benefits of the participation of kidney transplant recipients in randomized clinical trials (<jats:styled-content style=\"fixed-case\">RCT<\/jats:styled-content>s) investigating new immunosuppressive therapies are unknown.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design and Setting<\/jats:title><jats:p>We included patients from 12 prospective phase<jats:styled-content style=\"fixed-case\">II<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">III RCT<\/jats:styled-content>s randomized to the experimental (G1, n=319) or standard\u2010of\u2010care internal control group (G2, n=118). We constructed two additional external control groups with (G3, n=319) or without (G4, n=319) matching inclusion\/exclusion criteria based on transplant date. The primary outcome analysis was the composite clinical efficacy failure, defined as biopsy\u2010proven acute rejection (<jats:styled-content style=\"fixed-case\">BPAR<\/jats:styled-content>), graft loss, death, or loss to follow\u2010up 12\u00a0months after kidney transplantation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Survival free of composite clinical efficacy failure was higher among participants in<jats:styled-content style=\"fixed-case\">RCT<\/jats:styled-content>, without difference between experimental or standard\u2010of\u2010care therapy (80<jats:bold>\u2219<\/jats:bold>3 vs 78<jats:bold>\u2219<\/jats:bold>0 vs 69<jats:bold>\u2219<\/jats:bold>9 vs 66<jats:bold>\u2219<\/jats:bold>1%,<jats:italic>P<\/jats:italic>&lt;.001), respectively. Patient (98.1 vs 99.2 vs 96.9 vs 91.8<jats:italic>P<\/jats:italic>&lt;.001) and graft (94.0 vs 98.3 vs 90.9 vs 82.4) survivals were also higher in G1 compared to G4, but no differences in survival free of<jats:styled-content style=\"fixed-case\">BPAR<\/jats:styled-content>were observed (85.3 vs 78.8 vs 82.8 vs 81.2<jats:italic>P<\/jats:italic>&gt;.05), respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>These findings suggested that new treatments investigated in kidney transplant recipients are not associated with detectable harm compared to standard of care.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ctr.13046","type":"journal-article","created":{"date-parts":[[2017,6,30]],"date-time":"2017-06-30T15:16:40Z","timestamp":1498835800000},"source":"Crossref","is-referenced-by-count":1,"title":["Limitations of the interpretation and extrapolation of clinical trial data in kidney transplant recipients"],"prefix":"10.1111","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6401-3028","authenticated-orcid":false,"given":"Nagilla I.","family":"de Oliveira","sequence":"first","affiliation":[{"name":"Hospital do Rim Sao Paulo Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mayara I.","family":"Paula","sequence":"additional","affiliation":[{"name":"Hospital do Rim Sao Paulo Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudia R.","family":"Felipe","sequence":"additional","affiliation":[{"name":"Hospital do Rim Sao Paulo Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helio","family":"Tedesco\u2010Silva","sequence":"additional","affiliation":[{"name":"Hospital do Rim Sao Paulo Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jose O.","family":"Medina\u2010Pestana","sequence":"additional","affiliation":[{"name":"Hospital do Rim Sao Paulo Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,7,28]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurjhf\/hfp133"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(99)70400-2"},{"key":"e_1_2_8_4_1","unstructured":"KerrDJ KnoxK RobertsonDC StewartD WatsonR.ECRI Health Technology Assessment Information Service.Patients\u2019 Reasons for participation in clinical trials and effect of trial participation on patient outcomes. 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