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Candidate Surrogate...
Candidate Surrogate End Points for ESRD after AKI
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- Grams, Morgan E (author)
- Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
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- Sang, Yingying (author)
- Departments of Epidemiology, Baltimore, Maryland, USA
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- 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
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- Matsushita, Kunihiro (author)
- Departments of Epidemiology, Baltimore, Maryland, USA
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- Levey, Andrew S (author)
- Departments of Epidemiology, Baltimore, Maryland, USA
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- Greene, Tom H (author)
- Division of Clinical Epidemiology, University of Utah School of Medicine, Salt Lake City, Utah, USA
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- Molnar, Miklos Z (author)
- Division of Nephrology, University of Tennessee Health Science Center, Memphis, Tennessee, USA
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- Szabó, Zoltán (author)
- Linköpings universitet,Avdelningen för kardiovaskulär medicin,Medicinska fakulteten,Region Östergötland, Thorax-kärlkliniken i Östergötland
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- Kalantar-Zadeh, Kamyar (author)
- University of California Irvine Medical Center, Irvine, California, USA
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- 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.
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In: Journal of the American Society of Nephrology. - : American Society of Nephrology. - 1046-6673 .- 1533-3450. ; 27:9, s. 2851-2859
- Related links:
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https://liu.diva-por... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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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
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Grams, Morgan E
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Sang, Yingying
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Coresh, Josef
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Ballew, Shoshana ...
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Matsushita, Kuni ...
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Levey, Andrew S
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Greene, Tom H
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Molnar, Miklos Z
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Szabó, Zoltán
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Kalantar-Zadeh, ...
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Kovesdy, Csaba P
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
- Articles in the publication
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Journal of the A ...
- By the university
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Linköping University