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Estimated GFR and surrogate end point

Kalani L Raphael, Sarah Gilligan, Joachim H Ix
BACKGROUND AND OBJECTIVES: Low urine ammonium excretion is associated with ESRD in CKD. Few laboratories measure urine ammonium, limiting clinical application. We determined correlations between urine ammonium, the standard urine anion gap, and a modified urine anion gap that includes sulfate and phosphate and compared risks of ESRD or death between these ammonium estimates and directly measured ammonium. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We measured ammonium, sodium, potassium, chloride, phosphate, and sulfate from baseline 24-hour urine collections in 1044 African-American Study of Kidney Disease and Hypertension participants...
February 7, 2018: Clinical Journal of the American Society of Nephrology: CJASN
Casey M Rebholz, Lesley A Inker, Yuan Chen, Menglu Liang, Meredith C Foster, John H Eckfeldt, Paul L Kimmel, Ramachandran S Vasan, Harold I Feldman, Mark J Sarnak, Chi-Yuan Hsu, Andrew S Levey, Josef Coresh
BACKGROUND: Using change in estimated glomerular filtration rate (eGFR) based on creatinine concentration as a surrogate outcome in clinical trials of chronic kidney disease has been proposed. Risk for end-stage renal disease (ESRD) and all-cause mortality associated with change in concentrations of other filtration markers has not been studied in chronic kidney disease populations. STUDY DESIGN: Observational analysis of 2 clinical trials. SETTING & PARTICIPANTS: Participants in the MDRD (Modification of Diet in Renal Disease; n=317) Study and AASK (African American Study of Kidney Disease and Hypertension; n=373)...
October 2017: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
Rajiv Agarwal
Unlike definition of stroke and myocardial infarction, there is no uniformly agreed upon definition to adjudicate end-stage renal disease (ESRD). ESRD remains the most unambiguous and clinically relevant end point for clinical trialists, regulators, payers and patients with chronic kidney disease. The prescription of dialysis to patients with advanced chronic kidney disease is subjective and great variations exist among physicians and countries. Given the difficulties in diagnosing ESRD, the presence of estimated GFR <15 mL/min/1...
June 2016: Nephrology, Dialysis, Transplantation
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
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
Davide Bolignano, Suetonia C Palmer, Sankar D Navaneethan, Giovanni F M Strippoli
BACKGROUND: Treatment with angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) is increasingly used to reduce proteinuria and retard the progression of chronic kidney disease (CKD). However, resolution of proteinuria may be incomplete with these therapies and the addition of an aldosterone antagonist may be added to further prevent progression of CKD. This is an update of a review first published in 2009. OBJECTIVES: To evaluate the effect of aldosterone antagonists (both selective (eplerenone) and non-selective (spironolactone)) alone or in combination with ACEi or ARB in adults who have CKD with proteinuria (nephrotic and non-nephrotic range) on: patient-centred endpoints including major cardiovascular events, hospitalisation and all-cause mortality; kidney function (proteinuria, glomerular filtration rate (GFR), serum creatinine, and need for renal replacement therapy; and adverse events (including gynaecomastia and hyperkalaemia)...
April 29, 2014: Cochrane Database of Systematic Reviews
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
M H J Heeg, G A Mueller, C Bramlage, K Homayounfar, J Muehlhausen, A Leha, M J Koziolek
BACKGROUND: The most common immunosuppressive regimens after renal transplantation include calcineurin inhibitors (CNI). However, due to renal toxicity long-term graft survival does not seem to be positively affected by CNIs. METHODS: In the present study, we investigated 17 patients, in which the CNI immunosuppression was converted to a CNI-free, mycophenolate sodium (MPS) regimen. Conversion was performed due to progressive impairment of the graft function from suspected CNI toxicity...
January 2013: Transplantation Proceedings
Christine A White, Deborah Siegal, Ayub Akbari, Greg A Knoll
BACKGROUND: Clinical trials in kidney transplantation are beginning to include markers of kidney function as end points now that traditional outcomes, such as acute rejection, become increasingly rare events. The frequency and type of kidney function end points used are unknown. STUDY DESIGN: Systematic review. SETTING & POPULATION: Randomized controlled trials in adult kidney transplant recipients reported in 5 major general medical journals and 5 major subspecialty journals in nephrology and transplantation between January 2003 and November 2008...
December 2010: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
C R Lenihan, P O'Kelly, P Mohan, D Little, J J Walshe, N E Kieran, P J Conlon
Renal transplantation is the optimal mode of renal replacement. Improvements in graft survival and acute rejection rates have made these outcomes less useful for prognostication and as end-points in clinical trials; accurate surrogate markers of long-term graft outcome are therefore increasingly important. This study examines the relationship between both serum creatinine (SCr(1 yr)) and MDRD estimated glomerular filtration rate measured at one year (eGFR(MDRD)(1 yr)) as predictors of graft survival. Data on 1,110 patients who received a renal transplant between 1989 and 2005 were extracted from the Irish Renal Transplant Registry...
2008: Renal Failure
Jutta Muscheites, Marianne Wigger, Erdmute Drueckler, Ilka Klaassen, Ulrike John, Simone Wygoda, Dagmar-Christiane Fischer, Guenther Kundt, Joachim Misselwitz, Dirk-E Müller-Wiefel, Dieter Haffner
Acute rejection episodes following pediatric renal transplantation have been progressively reduced by recent immunosuppressive regimens. Nevertheless, grafts continue to fail over time and surrogate parameters for long-term RGS are lacking. We investigated post-transplant renal function within the first yr as an independent predictor of long-term RGS in 104 pediatric first kidney transplant recipients (mean age 11.1 +/- 3.9 yr; mean follow-up 8.3 +/- 3.5 yr) transplanted between January 1989 and December 2000...
May 2009: Pediatric Transplantation
Ute Hoffmann, Bernhard Banas, Michael Fischereder, Bernhard K Krämer
N-acetylcysteine (NAC) has been suggested to prevent radiocontrast-induced nephropathy (RCIN) in patients with a reduced renal function. However, clinical studies have not been demonstrating this effect consistently. Also, reviews and meta-analyses dealing with the question of prevention of RCIN by NAC have been controversial. Nearly all investigators used serum creatinine as surrogate end point of their trials, and changes in serum creatinine concentrations are thought to reflect the extent of renal injury as primary outcome...
2004: Kidney & Blood Pressure Research
Guido Filler, Richard Browne, Mouin G Seikaly
Only with prospective randomized controlled trials is it possible to evaluate the several immunosuppressive regimens available to renal allograft recipients. Commonly used surrogate markers of clinical outcome, such as patient and graft survival, are constantly improving. Current immunosuppressive protocols have improved 1-yr graft survival to over 90%. The small differences in graft survival among the various immunosuppressive regimes require large patient cohorts in order to establish statistical significance...
February 2003: Pediatric Transplantation
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