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Total Kidney Volume Is a Prognostic Biomarker of Renal Function Decline and Progression to End-Stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease.
Perrone, Ronald D; Mouksassi, Mohamad-Samer; Romero, Klaus; Czerwiec, Frank S; Chapman, Arlene B; Gitomer, Berenice Y; Torres, Vicente E; Miskulin, Dana C; Broadbent, Steve; Marier, Jean F.
Afiliación
  • Perrone RD; Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston, Massachusetts, USA.
  • Mouksassi MS; Pharsight, Montreal, Quebec, Canada.
  • Romero K; Critical Path Institute, Tucson, Arizona, USA.
  • Czerwiec FS; Otsuka Pharmaceutical Development and Commercialization Inc., Global Clinical Development, Rockville, Maryland, USA.
  • Chapman AB; Division of Nephrology, University of Chicago, Chicago, Illinois, USA.
  • Gitomer BY; Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
  • Torres VE; Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Minnesota, USA.
  • Miskulin DC; Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston, Massachusetts, USA.
  • Broadbent S; Critical Path Institute, Tucson, Arizona, USA.
  • Marier JF; Pharsight, Montreal, Quebec, Canada.
Kidney Int Rep ; 2(3): 442-450, 2017 May.
Article en En | MEDLINE | ID: mdl-29142971
INTRODUCTION: Autosomal dominant polycystic kidney disease is the most common hereditary kidney disease. TKV is a promising imaging biomarker for tracking and predicting the natural history of autosomal dominant polycystic kidney disease. The prognostic value of TKV was evaluated, in combination with age and eGFR, for the outcomes of 30% decline in eGFR and progression to ESRD. Observational data including 2355 patients with TKV measurements were available. METHODS: Multivariable Cox models were developed to assess the prognostic value of age, TKV, height-adjusted TKV, eGFR, sex, race, and genotype for the probability of a 30% decline in eGFR or ESRD. RESULTS: TKV was the most important prognostic term for 30% decline in eGFR in autosomal dominant polycystic kidney disease patients with and without preserved baseline eGFR. For a 40-year-old subject with preserved eGFR (70 ml/min per 1.73 m2), the adjusted hazard ratios for a 30% decline in eGFR were 1.86 (95% CI, 1.65-2.10) for a 2-fold larger TKV (600 vs. 1200 ml) and 2.68 (95% CI, 2.22-3.24) for a 3-fold larger TKV (600 vs. 1800 ml), respectively. Hazard ratios for progression to ESRD for 2- and 3-fold larger TKV were 1.72 (95% CI, 1.49-1.99) and 2.36 (95% CI, 1.88-2.97), respectively. DISCUSSION: The capability to predict 30% decline in eGFR is a novel aspect of this study. TKV was formally qualified, both by FDA and EMA, as a prognostic enrichment biomarker for selecting patients at high risk for a progressive decline in renal function for inclusion in interventional clinical trials.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Prognostic_studies Idioma: En Revista: Kidney Int Rep Año: 2017 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Prognostic_studies Idioma: En Revista: Kidney Int Rep Año: 2017 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos