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

American Journal of Kidney Diseases

Volumn 64, Issue 6, 2014, Pages 821-835

  Levey, Andrew S ^a   Inker, Lesley A ^a   Matsushita, Kunihiro ^b   Greene, Tom ^c   Willis, Kerry ^d   Lewis, Edmund ^e   De Zeeuw, Dick ^f   Cheung, Alfred K ^g   Coresh, Josef ^b  

^a TUFTS MEDICAL CENTER   (United States)

^b JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^c UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^d NATIONAL KIDNEY FOUNDATION   (United States)

^e RUSH UNIVERSITY MEDICAL CENTER   (United States)

^f UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^g UNIVERSITY OF UTAH   (United States)

Author keywords

biomarker chronic kidney disease (CKD); eGFR trajectory; end stage renal disease (ESRD); estimated glomerular filtration rate (eGFR) decline; kidney disease outcome; kidney disease progression; Kidney end point; renal end point; renal function; serum creatinine; surrogate end point

Indexed keywords

CREATININE;

ALBUMINURIA; ARTICLE; CARDIOVASCULAR RISK; CHRONIC KIDNEY DISEASE; CLINICAL TRIAL (TOPIC); CREATININE BLOOD LEVEL; END STAGE RENAL DISEASE; FALSE NEGATIVE RESULT; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; GLOMERULUS CAPILLARY; GLOMERULUS FILTRATION RATE; HUMAN; KIDNEY TRANSPLANTATION; LONG TERM CARE; MEDICAL SOCIETY; META ANALYSIS (TOPIC); MORBIDITY; MORTALITY; PHASE 2 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIMULATION; STUDY DESIGN; SYSTEMATIC REVIEW (TOPIC); WORKSHOP; BIOASSAY; EDUCATION; NON PROFIT ORGANIZATION; PATHOPHYSIOLOGY; PHYSIOLOGY; RENAL INSUFFICIENCY, CHRONIC; STANDARDS; TRENDS; UNITED STATES;

CLINICAL TRIALS AS TOPIC; EDUCATION; ENDPOINT DETERMINATION; FOUNDATIONS; GLOMERULAR FILTRATION RATE; HUMANS; RENAL INSUFFICIENCY, CHRONIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84911459484     PISSN: 02726386     EISSN: 15236838     Source Type: Journal    
DOI: 10.1053/j.ajkd.2014.07.030     Document Type: Article

References (41)

1. National Kidney Foundation. GFR decline as an endpoint in clinical trials for CKD. 2012. http://www.kidney.org/professionals/research/research-info.cfm. Accessed November 26, 2013.
2. J. Coresh, T.C. Turin, and K. Matsushita Decline in estimated glomerular filtration rate and subsequent risk of end-stage renal disease and mortality JAMA 311 24 2014 2518 2531
3. L.A. Inker, H.J. Lambers Heerspink, and H. Mondal GFR decline as an alternative end point to kidney failure in clinical trials: a meta-analysis of treatment effects from 37 randomized trials Am J Kidney Dis 64 6 2014 848 859
4. H.J. Lambers Heerspink, H. Tighiouart, and Y. Sang GFR decline and subsequent risk of established kidney outcomes: a meta-analysis of 37 randomized controlled trials Am J Kidney Dis 64 6 2014 860 866
5. T. Greene, C.-C. Teng, and L.A. Inker Utility and validity of estimated GFR-based surrogate time-to-event end points in CKD: a simulation study Am J Kidney Dis 64 6 2014 867 879
6. A.J. Collins, R.N. Foley, and C. Herzog US Renal Data System 2012 annual data report Am J Kidney Dis 61 1 suppl 1 2013 e1 e480
7. G.F. Strippoli, J.C. Craig, and F.P. Schena The number, quality, and coverage of randomized controlled trials in nephrology J Am Soc Nephrol 15 2 2004 411 419
8. S.C. Palmer, M. Sciancalepore, and G.F. Strippoli Trial quality in nephrology: how are we measuring up? Am J Kidney Dis 58 3 2011 335 337
9. Biomarkers Definitions Working Group Biomarkers and surrogate endpoints: preferred definitions and conceptual framework Clin Pharmacol Ther 69 3 2001 89 95
10. Kidney Disease: Improving Global Outcomes (KDIGO). KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease Kidney Int Suppl 3 1 2013 1 150
11. B.R. Hemmelgarn, M.T. James, and B.J. Manns Rates of treated and untreated kidney failure in older vs younger adults JAMA 307 23 2012 2507 2515
12. M.C. Thomas, M.E. Cooper, S. Shahinfar, and B.M. Brenner Dialysis delayed is death prevented: a clinical perspective on the RENAAL Study Kidney Int 63 4 2003 1577 1579
13. K. Uhlig, and A.S. Levey Developing guidelines for chronic kidney disease: we should include all of the outcomes Ann Intern Med 156 8 2012 599 601
14. M. Bedford, C. Farmer, A. Levin, T. Ali, and P. Stevens Acute kidney injury and CKD: chicken or egg? Am J Kidney Dis 59 4 2012 485 491
15. R. Bellomo, J.A. Kellum, and C. Ronco Acute kidney injury Lancet 380 9843 2012 756 766
16. A.S. Levey, D. Cattran, and A. Friedman Proteinuria as a surrogate outcome in CKD: report of a scientific workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration Am J Kidney Dis 54 2 2009 205 226
17. N. Stoycheff, K. Pandya, and A. Okparavero Early change in proteinuria as a surrogate outcome in kidney disease progression: a systematic review of previous analyses and creation of a patient-level pooled dataset Nephrol Dial Transplant 26 3 2011 848 857
18. L.A. Inker, A.S. Levey, K. Pandya, N. Stoycheff, A. Okparavero, and T. Greene Early change in proteinuria as a surrogate end point for kidney disease progression: an individual patient meta-analysis Am J Kidney Dis 64 1 2014 74 85
19. K. Matsushita, M. van der Velde, and B.C. Astor Association of estimated glomerular filtration rate and albuminuria with all-cause and cardiovascular mortality in general population cohorts: a collaborative meta-analysis Lancet 375 9731 2010 2073 2081
20. M. van der Velde, K. Matsushita, and J. Coresh Lower estimated glomerular filtration rate and higher albuminuria are associated with all-cause and cardiovascular mortality. A collaborative meta-analysis of high-risk population cohorts Kidney Int 79 12 2011 1341 1352
21. R.T. Gansevoort, K. Matsushita, and M. van der Velde Lower estimated GFR and higher albuminuria are associated with adverse kidney outcomes. A collaborative meta-analysis of general and high-risk population cohorts Kidney Int 80 1 2011 93 104
22. B.C. Astor, K. Matsushita, and R.T. Gansevoort Lower estimated glomerular filtration rate and higher albuminuria are associated with mortality and end-stage renal disease. A collaborative meta-analysis of kidney disease population cohorts Kidney Int 79 12 2011 1331 1340
23. B.K. Mahmoodi, K. Matsushita, and M. Woodward Associations of kidney disease measures with mortality and end-stage renal disease in individuals with and without hypertension: a meta-analysis Lancet 380 9854 2012 1649 1661
24. C.S. Fox, K. Matsushita, and M. Woodward Associations of kidney disease measures with mortality and end-stage renal disease in individuals with and without diabetes: a meta-analysis Lancet 380 9854 2012 1662 1673
25. S.I. Hallan, K. Matsushita, and Y. Sang Age and association of kidney measures with mortality and end-stage renal disease JAMA 308 22 2012 2349 2360
26. D. Nitsch, M. Grams, and Y. Sang Associations of estimated glomerular filtration rate and albuminuria with mortality and renal failure by sex: a meta-analysis BMJ 346 2013 f324
27. C.P. Wen, K. Matsushita, and J. Coresh Relative risks of chronic kidney disease for mortality and end-stage renal disease across races are similar Kidney Int 86 2014 819 827
28. Modification of Diet in Renal Disease Study Group A.S. Levey, G.J. Beck, and J.P. Bosch Short-term effects of protein intake, blood pressure, and antihypertensive therapy on glomerular filtration rate in the Modification of Diet in Renal Disease Study J Am Soc Nephrol 7 10 1996 2097 2109
29. L.Y. Agodoa, L. Appel, and G.L. Bakris Effect of ramipril vs amlodipine on renal outcomes in hypertensive nephrosclerosis: a randomized controlled trial JAMA 285 21 2001 2719 2728
30. J.J. Gassman, T. Greene, and J.T. Wright Jr. Design and statistical aspects of the African American Study of Kidney Disease and Hypertension (AASK) J Am Soc Nephrol 14 7 suppl 2 2003 S154 S165
31. C.H. Schmid, J. Lau, M.W. McIntosh, and J.C. Cappelleri An empirical study of the effect of the control rate as a predictor of treatment efficacy in meta-analysis of clinical trials Stat Med 17 17 1998 1923 1942
32. D.M. Kent, and R.A. Hayward Limitations of applying summary results of clinical trials to individual patients: the need for risk stratification JAMA 298 10 2007 1209 1212
33. A.S. Levey, L.A. Inker, and J. Coresh GFR estimation: from physiology to public health Am J Kidney Dis 63 5 2014 820 834
34. L. Li, B.C. Astor, and J. Lewis Longitudinal progression trajectory of GFR among patients with CKD Am J Kidney Dis 59 4 2012 504 512
35. H.J. Heerspink, L. Liang, P. Smink, T. Greene, H.H. Parving, and D. De Zeeuw Longitudinal eGFR trajectories in patients with type 2 diabetes and nephropathy [ASN abstract FR-PO155] J Am Soc Nephrol 23 2012 404A
36. Modification of Diet in Renal Disease Study Group A.S. Levey, J.P. Bosch, and C.H. Coggins Effects of diet and antihypertensive therapy on creatinine clearance and serum creatinine concentration in the Modification of Diet in Renal Disease Study J Am Soc Nephrol 7 4 1996 556 566
37. A.S. Levey, L.A. Stevens, and C.H. Schmid A new equation to estimate glomerular filtration rate Ann Intern Med 150 9 2009 604 612
38. L.A. Inker, C.H. Schmid, and H. Tighiouart Estimating glomerular filtration rate from serum creatinine and cystatin C N Engl J Med 367 1 2012 20 29
39. M. Desai, N. Stockbridge, and R. Temple Blood pressure as an example of a biomarker that functions as a surrogate AAPS J 8 1 2006 E146 E152
40. K. Matsushita, B.K. Mahmoodi, and M. Woodward Comparison of risk prediction using the CKD-EPI equation and the MDRD Study equation for estimated glomerular filtration rate JAMA 307 18 2012 1941 1951
41. A.B. Chapman, J.E. Bost, and V.E. Torres Kidney volume and functional outcomes in autosomal dominant polycystic kidney disease Clin J Am Soc Nephrol 7 3 2012 479 486