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EGFR and surrogate end point

Daniel C Cattran, Esther D Kim, Heather Reich, Michelle Hladunewich, S Joseph Kim
Although change in proteinuria has been proposed as a surrogate for long-term prognosis in membranous nephropathy (MGN), variability in proteinuria levels and lag between these changes and acceptable end points, such as ESRD, has limited its utility. This cohort study examined the prognostic significance of remission duration in 376 patients with biopsy-proven idiopathic/primary MGN who achieved a remission after a period of nephrotic-range proteinuria. We defined complete remission (CR), partial remission (PR), and relapse as proteinuria ≤0...
October 18, 2016: Journal of the American Society of Nephrology: JASN
M L Patel, R Sachan, A Verma, R Kamal, K K Gupta
Chronic kidney disease (CKD) is associated with early mortality, decreased quality of life and increased health care expenditures. The aim of this study was to determine whether or not urinary NGAL (uNGAL) level is associated with renal damage and kidney disease progression in patients with CKD and to evaluate the predictive value of uNGAL in progression of CKD. Totally, 91 cases of CKD stage II, III, IV, and 50 age-matched healthy controls were enrolled. The follow-up end-point was 18 months; end-point of the study was progression to an estimated glomerular filtration rate (eGFR) of <15 ml/min and/or CKD stage V...
March 2016: Indian Journal of Nephrology
B O Zhang, Ming Cheng, Ming Yang, Shuai Han, Ying-Hui Zhang, Hong-Guang Shi, Liang Zhu, Xue-Zhi Zhao
Idiopathic membranous nephropathy (IMN) is one of the most common causes of nephrotic syndrome (NS) in adults. The latest study of the chronic kidney disease-prognosis consortium showed that a 30% decrease in the estimated glomerular filtration rate (eGFR) within 2 years could cover more patients and showed a better correlation with end-stage renal disease (ESRD), as compared with serum creatinine (SCr). The aim of the present study was to analyze prognostic factors of ESRD using a 30% decrease in eGFR within 2 years as the end-point...
February 2016: Biomedical Reports
Morgan E Grams, Yingying Sang, Josef Coresh, Shoshana H Ballew, Kunihiro Matsushita, Andrew S Levey, Tom H Greene, Miklos Z Molnar, Zoltan Szabo, Kamyar Kalantar-Zadeh, Csaba P Kovesdy
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...
September 2016: Journal of the American Society of Nephrology: JASN
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
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
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
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
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