Is a decline in estimated GFR an appropriate surrogate end point for renoprotection drug trials?
نویسندگان
چکیده
منابع مشابه
GFR decline as an end point for clinical trials in CKD: a scientific workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration.
The US Food and Drug Administration currently accepts halving of glomerular filtration rate (GFR), assessed as doubling of serum creatinine level, as a surrogate end point for the development of kidney failure in clinical trials of kidney disease progression. A doubling of serum creatinine level generally is a late event in chronic kidney disease (CKD); thus, there is great interest in consider...
متن کاملGFR decline as an alternative end point to kidney failure in clinical trials: a meta-analysis of treatment effects from 37 randomized trials.
BACKGROUND There is increased interest in using alternative end points for trials of kidney disease progression. The currently established end points of end-stage renal disease and doubling of serum creatinine level, equivalent to a 57% decline in estimated glomerular filtration rate (eGFR), are late events in chronic kidney disease (CKD), requiring large clinical trials with long follow-up. As...
متن کاملAre surrogate end points in drug-eluting stent trials reliable?
5-lipoxygenase gene disruption reduces amyloidpathology in a mouse model of Alzheimer’s disease. FASEB J 2008;22:1169 –78. 6. Manev R, Imbesi M, Uz T, Dzitoyeva S, Dimitrijevic N, Manev H. Effects of 5-lipoxygenase inhibitors MK-886 and caffeic acid in a model of forced swimming in wild-type and 5-lipoxygenase– deficient mice. Program 711.4/BB17. 2007 Neuroscience Meeting Planner. San Diego, CA...
متن کاملis ceftizoxime an appropriate surrogate for amikacin in neonatal sepsis treatment? a randomized clinical trial
neonatal sepsis, a life-threatening condition, presents with non-specific clinical manifestations and needs immediate empirical antimicrobial therapy. choosing an appropriate antibiotic regimen covering the most probable pathogens is an important issue. in this study we compared the effectiveness of ceftizoxime and amikacin in the treatment of neonatal sepsis both in combination with ampicillin...
متن کاملArterial stiffness as surrogate end point: needed clinical trials.
Classic risk scores may underestimate the risk of cardiovascular (CV) events in specific risk groups suitable for primary prevention, such as asymptomatic hypertensive subjects. Particularly, those considered as at intermediate risk may benefit the most from a reassessment of their CV risk using novel biomarkers. In primary prevention, some imaging biomarkers, such as arterial stiffness, enhanc...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Kidney International
سال: 2014
ISSN: 0085-2538
DOI: 10.1038/ki.2013.506