Open AccessPrognostic enrichment design in clinical trials for autosomal dominant polycystic kidney disease: the HALT-PKD clinical trial
Author(s) -
María V. Irazabal,
Kaleab Z. Abebe,
Kyongtae Ty Bae,
Ronald D. Perrone,
Arlene B. Chapman,
Robert W. Schrier,
Alan S.L. Yu,
William E. Braun,
Theodore I. Steinman,
Peter C. Harris,
Michael F. Flessner,
Vicente E. Torres,
the HALT Investigators
Publication year - 2016
Publication title -
nephrology dialysis transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.654
H-Index - 168
eISSN - 1460-2385
pISSN - 0931-0509
DOI - 10.1093/ndt/gfw294
Subject(s) - medicine , autosomal dominant polycystic kidney disease , renal function , cyst , polycystic kidney disease , clinical trial , disease , kidney disease , post hoc analysis , urology , randomized controlled trial , oncology , endocrinology , gastroenterology , pathology
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-E 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).
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