keyword
MENU ▼
Read by QxMD icon Read
search

Decline in estimated GFR and surrogate end point

keyword
https://www.readbyqxmd.com/read/26163881/glomerular-filtration-rate-decline-as-a-surrogate-end-point-in-kidney-disease-progression-trials
#1
REVIEW
Sunil V Badve, Suetonia C Palmer, Carmel M Hawley, Elaine M Pascoe, Giovanni F M Strippoli, David W Johnson
Chronic kidney disease (CKD) is strongly associated with increased risks of progression to end-stage kidney disease (ESKD) and mortality. Clinical trials evaluating CKD progression commonly use a composite end point of death, ESKD or serum creatinine doubling. However, due to low event rates, such trials require large sample sizes and long-term follow-up for adequate statistical power. As a result, very few interventions targeting CKD progression have been tested in randomized controlled trials. To overcome this problem, the National Kidney Foundation and Food and Drug Administration conducted a series of analyses to determine whether an end point of 30 or 40% decline in estimated glomerular filtration rate (eGFR) over 2-3 years can substitute for serum creatinine doubling in the composite end point...
September 2016: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/25542414/change-in-novel-filtration-markers-and-risk-of-esrd
#2
Casey M Rebholz, Morgan E Grams, Kunihiro Matsushita, Elizabeth Selvin, Josef Coresh
BACKGROUND: Chronic kidney disease progression is a risk factor for end-stage renal disease (ESRD). A 57% decline in creatinine-based estimated glomerular filtration rate (eGFRcr) is an established surrogate outcome for ESRD in clinical trials, and a 30% decrease recently has been proposed as a surrogate end point. However, it is unclear whether change in novel filtration marker levels provides additional information for ESRD risk to change in eGFRcr. STUDY DESIGN: Cohort study...
July 2015: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
https://www.readbyqxmd.com/read/25441440/utility-and-validity-of-estimated-gfr-based-surrogate-time-to-event-end-points-in-ckd-a-simulation-study
#3
Tom Greene, Chia-Chen Teng, Lesley A Inker, Andrew Redd, Jian Ying, Mark Woodward, Josef Coresh, Andrew S Levey
BACKGROUND: There is interest in surrogate end points for clinical trials of chronic kidney disease progression because currently established end points-end-stage renal disease (ESRD) and doubling of serum creatinine level-are late events, requiring large clinical trials with long follow-up. Doubling of serum creatinine level is equivalent to a 57% decline in estimated glomerular filtration rate (eGFR). We evaluated type 1 error and required sample size for clinical trials using surrogate end points based on lesser eGFR declines...
December 2014: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
https://www.readbyqxmd.com/read/25441438/gfr-decline-as-an-alternative-end-point-to-kidney-failure-in-clinical-trials-a-meta-analysis-of-treatment-effects-from-37-randomized-trials
#4
Lesley A Inker, Hiddo J Lambers Heerspink, Hasi Mondal, Christopher H Schmid, Hocine Tighiouart, Farzad Noubary, Josef Coresh, Tom Greene, Andrew S Levey
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 part of a comprehensive evaluation of lesser declines in eGFR as alternative end points, we describe the consistency of treatment effects of intervention on the alternative and established end points in past trials...
December 2014: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
https://www.readbyqxmd.com/read/25441437/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
#5
REVIEW
Andrew S Levey, Lesley A Inker, Kunihiro Matsushita, Tom Greene, Kerry Willis, Edmund Lewis, Dick de Zeeuw, Alfred K Cheung, Josef Coresh
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 considering alternative end points for clinical trials to shorten their duration, reduce sample size, and extend their conduct to patients with earlier stages of CKD...
December 2014: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
https://www.readbyqxmd.com/read/24210590/estimated-gfr-decline-as-a-surrogate-end-point-for-kidney-failure-a-post-hoc-analysis-from-the-reduction-of-end-points-in-non-insulin-dependent-diabetes-with-the-angiotensin-ii-antagonist-losartan-renaal-study-and-irbesartan-diabetic-nephropathy-trial-idnt
#6
RANDOMIZED CONTROLLED TRIAL
Hiddo J Lambers Heerspink, Misghina Weldegiorgis, Lesley A Inker, Ron Gansevoort, Hans-Henrik Parving, Jamie P Dwyer, Hasi Mondal, Josef Coresh, Tom Greene, Andrew S Levey, Dick de Zeeuw
BACKGROUND: A doubling of serum creatinine value, corresponding to a 57% decline in estimated glomerular filtration rate (eGFR), is used frequently as a component of a composite kidney end point in clinical trials in type 2 diabetes. The aim of this study was to determine whether alternative end points defined by smaller declines in eGFR would improve the statistical power of these clinical trials. STUDY DESIGN: Post hoc analyses of 2 multinational randomized controlled trials (Reduction of End Points in Non-Insulin-Dependent Diabetes With the Angiotensin II Antagonist Losartan [RENAAL] and Irbesartan Diabetic Nephropathy Trial [IDNT]) that assessed the treatment effect of the angiotensin receptor blockers (ARBs) losartan and irbesartan...
February 2014: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
1
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"