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2014 ; 127
(1-4
): 89-93
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Clinical trial endpoints in acute kidney injury
#MMPMID25343828
Billings FT 4th
; Shaw AD
Nephron Clin Pract
2014[]; 127
(1-4
): 89-93
PMID25343828
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The development and use of consensus criteria for acute kidney injury (AKI)
diagnosis and the inclusion of recently identified markers of renal parenchymal
damage as endpoints in clinical trials have improved the ability of physicians to
compare the incidence and severity of AKI across patient populations, provided
targets for testing new treatments, and may increase insight into the mechanisms
of AKI. To date, these markers have not consistently translated into important
clinical outcomes. Is that because these markers of renal injury/dysfunction are
measurements of process of care (and not indicative of persistently impaired
renal function), or is it because patients do actually recover from AKI?
Physicians currently have limited ability to measure renal function reserve, and
the ultimate consequence of a case of AKI on long-term morbidity remains unclear.
There is little doubt that groups of patients who develop AKI have worse outcomes
than groups of patients who do not, but investigators are now realizing the value
of measuring clinically meaningful renal endpoints in all subjects enrolled in
AKI clinical trials. Important examples of these outcomes include persistently
impaired renal function, new hemodialysis, and death. We propose that these major
adverse kidney events (MAKE) be included in all effectiveness clinical trials.
Adaptation of the MAKE composite assessed 30, 60, or 90 days following AKI (i.e.,
MAKE30 or MAKE90) will improve our capacity to understand and treat AKI and may
also provide a consensus composite to allow comparison of different
interventions. Primary endpoints for phase I and II clinical trials, on the other
hand, should continue to use continuous markers of renal injury/dysfunction as
well as 'hard' clinical outcomes in order to generate meaningful data with
limited subject exposure to untested treatments. By doing so, investigators may
assess safety without requiring large sample sizes, demonstrate treatment effect
of an unknown therapeutic, and power subsequent studies. In contrast, phase III
trials should include consensus AKI criteria and more important subsequent
clinical outcomes, such as MAKE90, as primary endpoints.
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