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Candidate Surrogate End Points for ESRD after AKI

Grams, Morgan E (author)
Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
Sang, Yingying (author)
Departments of Epidemiology, Baltimore, Maryland, USA
Coresh, Josef (author)
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
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Ballew, Shoshana H (author)
Departments of Epidemiology, Baltimore, Maryland, USA
Matsushita, Kunihiro (author)
Departments of Epidemiology, Baltimore, Maryland, USA
Levey, Andrew S (author)
Departments of Epidemiology, Baltimore, Maryland, USA
Greene, Tom H (author)
Division of Clinical Epidemiology, University of Utah School of Medicine, Salt Lake City, Utah, USA
Molnar, Miklos Z (author)
Division of Nephrology, University of Tennessee Health Science Center, Memphis, Tennessee, USA
Szabó, Zoltán (author)
Linköpings universitet,Avdelningen för kardiovaskulär medicin,Medicinska fakulteten,Region Östergötland, Thorax-kärlkliniken i Östergötland
Kalantar-Zadeh, Kamyar (author)
University of California Irvine Medical Center, Irvine, California, USA
Kovesdy, Csaba P (author)
University of Tennessee Health Science Center, Memphis, Tennessee, USA
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 (creator_code:org_t)
American Society of Nephrology, 2016
2016
English.
In: Journal of the American Society of Nephrology. - : American Society of Nephrology. - 1046-6673 .- 1533-3450. ; 27:9, s. 2851-2859
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  • Journal article (peer-reviewed)
Abstract Subject headings
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  • AKI, a frequently transient condition, is not accepted by the US Food and Drug Association as an end point for drug registration trials. We assessed whether an intermediate-term change in eGFR after AKI has a sufficiently strong relationship with subsequent ESRD to serve as an alternative end point in trials of AKI prevention and/or treatment. Among 161,185 United States veterans undergoing major surgery between 2004 and 2011, we characterized in-hospital AKI by Kidney Disease Improving Global Outcomes creatinine criteria and decline in eGFR from prehospitalization to postdischarge time points and quantified associations of these values with ESRD and mortality over a median of 3.8 years. An eGFR decline of ≥30% at 30, 60, and 90 days after discharge occurred in 3.1%, 2.5%, and 2.6%, of survivors without AKI and 15.9%, 12.2%, and 11.7%, of survivors with AKI. For patients with in-hospital AKI compared with those with no AKI and stable eGFR, a 30% decline in eGFR at 30, 60, and 90 days after discharge demonstrated adjusted hazard ratios (95% confidence intervals) of ESRD of 5.60 (4.06 to 7.71), 6.42 (4.76 to 8.65), and 7.27 (5.14 to 10.27), with corresponding estimates for 40% decline in eGFR of 6.98 (5.21 to 9.35), 8.03 (6.11 to 10.56), and 10.95 (8.10 to 14.82). Risks for mortality were smaller but consistent in direction. A 30%-40% decline in eGFR after AKI could be a surrogate end point for ESRD in trials of AKI prevention and/or treatment, but additional trial evidence is needed.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine (hsv//eng)

Keyword

acute renal failure
end stage kidney disease
glomerular filtration rate

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ref (subject category)
art (subject category)

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