{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T04:12:18Z","timestamp":1785730338311,"version":"3.56.0"},"reference-count":23,"publisher":"Oxford University Press (OUP)","issue":"11","funder":[{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["DK62402 to V.E.T., DK082230 to R.W.S., DK62411 to R.D.P., DK62410 to Dr Moore, DK62408 to A.B.C., DK62401"],"award-info":[{"award-number":["DK62402 to V.E.T., DK082230 to R.W.S., DK62411 to R.D.P., DK62410 to Dr Moore, DK62408 to A.B.C., DK62401"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006108","name":"National Center for Advancing Translational Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006108","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100010174","name":"University of Colorado","doi-asserted-by":"publisher","award":["RR023940"],"award-info":[{"award-number":["RR023940"]}],"id":[{"id":"10.13039\/100010174","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006727","name":"University of Kansas Medical Center","doi-asserted-by":"publisher","award":["RR001032"],"award-info":[{"award-number":["RR001032"]}],"id":[{"id":"10.13039\/100006727","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006939","name":"Emory University","doi-asserted-by":"publisher","award":["RR025752 and TR001064"],"award-info":[{"award-number":["RR025752 and TR001064"]}],"id":[{"id":"10.13039\/100006939","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100008090","name":"Tufts University","doi-asserted-by":"publisher","award":["RR025780 and TR001082"],"award-info":[{"award-number":["RR025780 and TR001082"]}],"id":[{"id":"10.13039\/100008090","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100010174","name":"University of Colorado","doi-asserted-by":"publisher","award":["RR025758 and TR001102"],"award-info":[{"award-number":["RR025758 and TR001102"]}],"id":[{"id":"10.13039\/100010174","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005615","name":"Beth Israel Deaconess Medical Center","doi-asserted-by":"publisher","award":["RR033179 and TR000001"],"award-info":[{"award-number":["RR033179 and TR000001"]}],"id":[{"id":"10.13039\/100005615","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006727","name":"University of Kansas Medical Center","doi-asserted-by":"publisher","award":["RR024989 and TR000439"],"award-info":[{"award-number":["RR024989 and TR000439"]}],"id":[{"id":"10.13039\/100006727","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2017,11,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Patients with mild autosomal dominant polycystic kidney disease (ADPKD) are less likely to be informative in randomized clinical trials (RCTs). We previously developed an imaging classification of ADPKD (typical diffuse cyst distribution Class 1A\u2013E and atypical cyst distribution Class 2) for prognostic enrichment design in RCTs. We investigated whether using this classification would have increased the power to detect a beneficial treatment effect of rigorous blood pressure (BP) control on HALT-PKD participants with early disease (Study A).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Post hoc analysis of the early disease HALT-PKD study, an RCT that studied the effect of rigorous versus standard BP control on rates of total kidney volume (TKV) increase and estimated glomerular filtration rate (eGFR) decline in ADPKD patients with eGFR &amp;gt;60 mL\/min\/1.73 m2.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Five hundred and fifty-one patients were classified by two observers (98.2% agreement) into Class 1A (6.2%), 1B (20.3%), 1C (34.1%), 1D (22.1%), 1E (11.8%) and 2 (5.4%). The TKV increase and eGFR decline became steeper from Class 1A through 1E. Rigorous BP control had been shown to be associated with slower TKV increase, without a significant overall effect on the rate of eGFR decline (faster in the first 4 months and marginally slower thereafter). Merging Classes 1A and 2 (lowest severity), 1B and 1C (intermediate severity) and 1D and 1E (highest severity) detected stronger beneficial effects on TKV increase and eGFR decline in Class 1D and E with a smaller number of patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Strategies for prognostic enrichment, such as image classification, should be used in the design of RCTs for ADPKD to increase their power and reduce their cost.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ndt\/gfw294","type":"journal-article","created":{"date-parts":[[2016,8,2]],"date-time":"2016-08-02T20:34:22Z","timestamp":1470170062000},"page":"1857-1865","source":"Crossref","is-referenced-by-count":26,"title":["Prognostic enrichment design in clinical trials for autosomal dominant polycystic kidney disease: the HALT-PKD clinical trial"],"prefix":"10.1093","volume":"32","author":[{"given":"Mar\u00eda V","family":"Irazabal","sequence":"first","affiliation":[{"name":"1Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55905, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaleab Z","family":"Abebe","sequence":"additional","affiliation":[{"name":"2University of Pittsburgh School of Medicine, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyongtae Ty","family":"Bae","sequence":"additional","affiliation":[{"name":"2University of Pittsburgh School of Medicine, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald D","family":"Perrone","sequence":"additional","affiliation":[{"name":"3Tufts Medical Center, Boston, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arlene B","family":"Chapman","sequence":"additional","affiliation":[{"name":"4Division of Nephrology, University of Chicago, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert W","family":"Schrier","sequence":"additional","affiliation":[{"name":"5University of Colorado, Denver, CO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan S","family":"Yu","sequence":"additional","affiliation":[{"name":"6Kansas University Medical Center, Kansas City, KS, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William E","family":"Braun","sequence":"additional","affiliation":[{"name":"7Cleveland Clinic, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Theodore I","family":"Steinman","sequence":"additional","affiliation":[{"name":"8Beth Israel Deaconess Medical Center, Boston, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter C","family":"Harris","sequence":"additional","affiliation":[{"name":"1Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55905, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael F","family":"Flessner","sequence":"additional","affiliation":[{"name":"9National Institutes of Health, Bethesda, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vicente E","family":"Torres","sequence":"additional","affiliation":[{"name":"1Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55905, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the HALT 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