메뉴 건너뛰기




Volumn 24, Issue 6, 2015, Pages 492-497

Surrogate endpoints in clinical trials of chronic kidney disease progression: Moving from single to multiple risk marker response scores

Author keywords

biomarkers, end stage renal disease, glomerular filtration rate, nephrology, surrogate endpoints

Indexed keywords

ALBUMIN; ATRASENTAN; BIOLOGICAL MARKER; CREATININE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; IRBESARTAN; LOSARTAN; PENTOXIFYLLINE; XANTHINE DERIVATIVE;

EID: 84944076978     PISSN: 10624821     EISSN: 14736543     Source Type: Journal    
DOI: 10.1097/MNH.0000000000000159     Document Type: Review
Times cited : (5)

References (45)
  • 1
    • 84929606033 scopus 로고    scopus 로고
    • Worldwide access to treatment for end-stage kidney disease: A systematic review
    • Liyanage T, Ninomiya T, Jha V, et al. Worldwide access to treatment for end-stage kidney disease: a systematic review. Lancet 2015; 385:1975-1982.
    • (2015) Lancet , vol.385 , pp. 1975-1982
    • Liyanage, T.1    Ninomiya, T.2    Jha, V.3
  • 2
    • 0035922441 scopus 로고    scopus 로고
    • Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy
    • Brenner BM, Cooper ME, de Zeeuw D, et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med 2001; 345:861-869.
    • (2001) N Engl J Med , vol.345 , pp. 861-869
    • Brenner, B.M.1    Cooper, M.E.2    De Zeeuw, D.3
  • 3
    • 0035922447 scopus 로고    scopus 로고
    • Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes
    • Lewis EJ, Hunsicker LG, Clarke WR, et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med 2001; 345:851-860.
    • (2001) N Engl J Med , vol.345 , pp. 851-860
    • Lewis, E.J.1    Hunsicker, L.G.2    Clarke, W.R.3
  • 4
    • 84869492851 scopus 로고    scopus 로고
    • Cardiorenal end points in a trial of aliskiren for type 2 diabetes
    • Parving H, Brenner BM, McMurray JJV, et al. Cardiorenal end points in a trial of aliskiren for type 2 diabetes. N Engl J Med 2012; 367:2204-2213.
    • (2012) N Engl J Med , vol.367 , pp. 2204-2213
    • Parving, H.1    Brenner, B.M.2    Jjv, M.3
  • 6
    • 0037374498 scopus 로고    scopus 로고
    • The price of innovation: New estimates of drug development costs
    • DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ 2003; 22:151-185.
    • (2003) J Health Econ , vol.22 , pp. 151-185
    • DiMasi, J.A.1    Hansen, R.W.2    Grabowski, H.G.3
  • 7
    • 77149155968 scopus 로고    scopus 로고
    • Trends in risks associated with new drug development: Success rates for investigational drugs
    • DiMasi JA, Feldman L, Seckler A, Wilson A. Trends in risks associated with new drug development: success rates for investigational drugs. Clin Pharmacol Ther 2010; 87:272-277.
    • (2010) Clin Pharmacol Ther , vol.87 , pp. 272-277
    • DiMasi, J.A.1    Feldman, L.2    Seckler, A.3    Wilson, A.4
  • 8
    • 0035100888 scopus 로고    scopus 로고
    • Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework
    • Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 2001; 69:89-95.
    • (2001) Clin Pharmacol Ther , vol.69 , pp. 89-95
  • 9
    • 84911459484 scopus 로고    scopus 로고
    • 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
    • Levey AS, Inker LA, Matsushita K, et al. 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. Am J Kidney Dis 2015; 64:821-835.
    • (2015) Am J Kidney Dis , vol.64 , pp. 821-835
    • Levey, A.S.1    Inker, L.A.2    Matsushita, K.3
  • 10
    • 84911421306 scopus 로고    scopus 로고
    • GFR decline as an alternative end point to kidney failure in clinical trials: A meta-analysis of treatment effects from 37 randomized trials
    • Inker LA, Lambers Heerspink HJ, Mondal H, et al. 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 2015; 64:848-859.
    • (2015) Am J Kidney Dis , vol.64 , pp. 848-859
    • Inker, L.A.1    Lambers Heerspink, H.J.2    Mondal, H.3
  • 11
    • 84902826499 scopus 로고    scopus 로고
    • Decline in estimated glomerular filtration rate and subsequent risk of end-stage renal disease and mortality
    • Coresh J, Turin T, Matsushita K, et al. Decline in estimated glomerular filtration rate and subsequent risk of end-stage renal disease and mortality. JAMA 2014; 311:2518-2531.
    • (2014) JAMA , vol.311 , pp. 2518-2531
    • Coresh, J.1    Turin, T.2    Matsushita, K.3
  • 12
    • 84892925764 scopus 로고    scopus 로고
    • EGFR 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)
    • Lambers Heerspink HJ, Weldegiorgis M, Inker LA, et al. eGFR 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). Am J Kidney Dis 2014; 63:244-250.
    • (2014) Am J Kidney Dis , vol.63 , pp. 244-250
    • Lambers Heerspink, H.J.1    Weldegiorgis, M.2    Inker, L.A.3
  • 13
    • 84910629666 scopus 로고    scopus 로고
    • Surrogate outcomes for ESRD Risk: The case for a 30% reduction in estimated GFR over 2 years
    • Sontrop JM, Weir MA, Garg AX. Surrogate outcomes for ESRD Risk: the case for a 30% reduction in estimated GFR over 2 years. Am J Kidney Dis 2014; 64:845-847.
    • (2014) Am J Kidney Dis , vol.64 , pp. 845-847
    • Sontrop, J.M.1    Weir, M.A.2    Garg, A.X.3
  • 14
    • 84911421938 scopus 로고    scopus 로고
    • GFR decline and subsequent risk of established kidney outcomes: A meta-analysis of 37 randomized controlled trials
    • Lambers Heerspink HJ, Tighiouart H, Sang Y, et al. GFR decline and subsequent risk of established kidney outcomes: a meta-analysis of 37 randomized controlled trials. Am J Kidney Dis 2015; 64:860-866.
    • (2015) Am J Kidney Dis , vol.64 , pp. 860-866
    • Lambers Heerspink, H.J.1    Tighiouart, H.2    Sang, Y.3
  • 15
    • 84910645074 scopus 로고    scopus 로고
    • Utility and validity of estimated GFR-based surrogate time-to-event end points in CKD: A simulation study
    • Greene T, Teng C, Inker LA, et al. Utility and validity of estimated GFR-based surrogate time-to-event end points in CKD: a simulation study. Am J Kidney Dis 2015; 64:867-879.
    • (2015) Am J Kidney Dis , vol.64 , pp. 867-879
    • Greene, T.1    Teng, C.2    Inker, L.A.3
  • 16
    • 85067727731 scopus 로고    scopus 로고
    • Draft guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency
    • [Accessed 16 April 2015]
    • European Medicines Agency. Draft guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency. EMA/CHMP/355988/2014. 2014; Available at: http://www.ema.europa.eu/ema/doc-index.jsp?curl=pages/includes/document/document-detail.jsp?webContentId=WC500169469&murl=menus/document- library/document-library.jsp&mid=0b01ac058009a3dc. [Accessed 16 April 2015]
    • (2014) EMA/CHMP/355988/2014
    • European Medicines Agency.1
  • 17
    • 79960407033 scopus 로고    scopus 로고
    • An acute fall in estimated glomerular filtration rate during treatment with losartan predicts a slower decrease in long-term renal function
    • Holtkamp FA, de Zeeuw D, Thomas MC, et al. An acute fall in estimated glomerular filtration rate during treatment with losartan predicts a slower decrease in long-term renal function. Kidney Int 2011; 80:282-287.
    • (2011) Kidney Int , vol.80 , pp. 282-287
    • Holtkamp, F.A.1    De Zeeuw, D.2    Thomas, M.C.3
  • 18
    • 79960410637 scopus 로고    scopus 로고
    • Acute fall in glomerular filtration rate with renin-angiotensin system inhibition: A biomeasure oftherapeutic success
    • Weir MR. Acute fall in glomerular filtration rate with renin-angiotensin system inhibition: a biomeasure oftherapeutic success. Kidney Int 2011; 80:235-237.
    • (2011) Kidney Int , vol.80 , pp. 235-237
    • Weir, M.R.1
  • 19
    • 29744469415 scopus 로고    scopus 로고
    • Recommendations for improving serum creatinine measurement: A report from the Laboratory Working Group of the National Kidney Disease Education Program
    • Myers GL, Miller WG, Coresh J, et al. Recommendations for improving serum creatinine measurement: a report from the Laboratory Working Group of the National Kidney Disease Education Program. Clin Chem 2006; 52:5-18.
    • (2006) Clin Chem , vol.52 , pp. 5-18
    • Myers, G.L.1    Miller, W.G.2    Coresh, J.3
  • 20
    • 84867055649 scopus 로고    scopus 로고
    • Clinical evaluation of analytical variations in serum creatinine measurements: Why laboratories should abandon Jaffe techniques
    • Drion I, Cobbaert C, Groenier K, et al. Clinical evaluation of analytical variations in serum creatinine measurements: why laboratories should abandon Jaffe techniques. BMC Nephrol 2012; 13:133.
    • (2012) BMC Nephrol , vol.13 , pp. 133
    • Drion, I.1    Cobbaert, C.2    Groenier, K.3
  • 21
    • 84879687867 scopus 로고    scopus 로고
    • The GFR and GFR decline cannot be accurately estimated in type 2 diabetics
    • Gaspari F, Ruggenenti P, Porrini E, et al. The GFR and GFR decline cannot be accurately estimated in type 2 diabetics. Kidney Int 2013; 84:164-173.
    • (2013) Kidney Int , vol.84 , pp. 164-173
    • Gaspari, F.1    Ruggenenti, P.2    Porrini, E.3
  • 22
    • 0035007504 scopus 로고    scopus 로고
    • A model for a proportional treatment effect on disease progression
    • Greene T. A model for a proportional treatment effect on disease progression. Biometrics 2001; 57:354-360.
    • (2001) Biometrics , vol.57 , pp. 354-360
    • Greene, T.1
  • 24
    • 84922764517 scopus 로고    scopus 로고
    • Microalbuminuria: A parameter that has changed diabetes care
    • Parving H, Persson F, Rossing P. Microalbuminuria: a parameter that has changed diabetes care. Diabetes Res Clin Pract 2015; 107:1-8.
    • (2015) Diabetes Res Clin Pract , vol.107 , pp. 1-8
    • Parving, H.1    Persson, F.2    Rossing, P.3
  • 25
    • 33750736645 scopus 로고    scopus 로고
    • How does proteinuria cause progressive renal damage?
    • Abbate M, Zoja C, Remuzzi G. How does proteinuria cause progressive renal damage? J Am Soc Nephrol 2006; 17:2974-2984.
    • (2006) J Am Soc Nephrol , vol.17 , pp. 2974-2984
    • Abbate, M.1    Zoja, C.2    Remuzzi, G.3
  • 26
    • 2442680120 scopus 로고    scopus 로고
    • Proteinuria, a target for renoprotec-tion in patients with type 2 diabetic nephropathy: Lessons from RENAAL
    • de Zeeuw D, Remuzzi G, Parving H, et al. Proteinuria, a target for renoprotec-tion in patients with type 2 diabetic nephropathy: Lessons from RENAAL. Kidney Int 2004; 65:2309-2320.
    • (2004) Kidney Int , vol.65 , pp. 2309-2320
    • De Zeeuw, D.1    Remuzzi, G.2    Parving, H.3
  • 27
    • 84855987525 scopus 로고    scopus 로고
    • Initial angiotensin receptor blockade-induced decrease in albuminuria is associated with long-term renal outcome in type 2 diabetic patients with microalbuminuria: A post hoc analysis of the IRMA-2 trial
    • Hellemons ME, Persson F, Bakker SJL, et al. Initial angiotensin receptor blockade-induced decrease in albuminuria is associated with long-term renal outcome in type 2 diabetic patients with microalbuminuria: a post hoc analysis of the IRMA-2 trial. Diabetes Care 2011; 34:2078-2083.
    • (2011) Diabetes Care , vol.34 , pp. 2078-2083
    • Hellemons, M.E.1    Persson, F.2    Sjl, B.3
  • 28
    • 20144363431 scopus 로고    scopus 로고
    • Proteinuria reduction and progression to renal failure in patients with type 2 diabetes mellitus and overt nephropathy
    • Atkins RC, Briganti EM, Lewis JB, et al. Proteinuria reduction and progression to renal failure in patients with type 2 diabetes mellitus and overt nephropathy. Am J Kidney Dis 2005; 45:281-287.
    • (2005) Am J Kidney Dis , vol.45 , pp. 281-287
    • Atkins, R.C.1    Briganti, E.M.2    Lewis, J.B.3
  • 29
    • 84924173941 scopus 로고    scopus 로고
    • Effect of pentoxifylline on renal function and urinary albumin excretion in patients with diabetic kidney disease: The PREDIAN Trial
    • Navarro-González JF, Mora-Fernández C, Muros de Fuentes M, et al. Effect of pentoxifylline on renal function and urinary albumin excretion in patients with diabetic kidney disease: The PREDIAN Trial. J Am Soc Nephrol 2015; 26:220-229.
    • (2015) J Am Soc Nephrol , vol.26 , pp. 220-229
    • Navarro-González, J.F.1    Mora-Fernández, C.2    Muros De Fuentes, M.3
  • 30
    • 84924081459 scopus 로고    scopus 로고
    • Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): A randomised clinical trial
    • de Zeeuw D, Anzalone DA, Cain VA, et al. Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): a randomised clinical trial. Lancet Diabetes Endocrinol 2015; 3:181-190.
    • (2015) Lancet Diabetes Endocrinol , vol.3 , pp. 181-190
    • De Zeeuw, D.1    Anzalone, D.A.2    Cain, V.A.3
  • 31
    • 59949085240 scopus 로고    scopus 로고
    • First morning voids are more reliable than spot urine samples to assess microalbuminuria
    • Witte EC, Lambers Heerspink HJ, de Zeeuw D, et al. First morning voids are more reliable than spot urine samples to assess microalbuminuria. J Am Soc Nephrol 2009; 20:436-443.
    • (2009) J Am Soc Nephrol , vol.20 , pp. 436-443
    • Witte, E.C.1    Lambers Heerspink, H.J.2    De Zeeuw, D.3
  • 32
    • 84924351689 scopus 로고    scopus 로고
    • Number and frequency of albuminuria measurements in clinical trials in diabetic nephropathy
    • Kröpelin TF, de Zeeuw D, Andress DL, et al. Number and frequency of albuminuria measurements in clinical trials in diabetic nephropathy. Clin J Am Soc Nephrol 2015; 10:410-416.
    • (2015) Clin J Am Soc Nephrol , vol.10 , pp. 410-416
    • Kröpelin, T.F.1    De Zeeuw, D.2    Andress, D.L.3
  • 33
    • 34249897487 scopus 로고    scopus 로고
    • Renoprotection of Optimal Antiproteinuric Doses (ROAD) Study: A randomized controlled study of benazepril and losartan in chronic renal insufficiency
    • Hou FF, Xie D, Zhang X, et al. Renoprotection of Optimal Antiproteinuric Doses (ROAD) Study: a randomized controlled study of benazepril and losartan in chronic renal insufficiency. J Am Soc Nephrol 2007; 18:1889-1898.
    • (2007) J Am Soc Nephrol , vol.18 , pp. 1889-1898
    • Hou, F.F.1    Xie, D.2    Zhang, X.3
  • 34
    • 79953787215 scopus 로고    scopus 로고
    • Increased serum potassium affects renal outcomes: A post hoc analysis of the Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) trial
    • Miao Y, Dobre D, Lambers Heerspink HJ, et al. Increased serum potassium affects renal outcomes: a post hoc analysis of the Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) trial. Diabe-tologia 2011; 54:44-50.
    • (2011) Diabe-tologia , vol.54 , pp. 44-50
    • Miao, Y.1    Dobre, D.2    Lambers Heerspink, H.J.3
  • 35
    • 84896697373 scopus 로고    scopus 로고
    • The effect of ramipril and telmisartan on serum potassium and its association with cardiovascular and renal events: Results from the ONTARGET trial
    • Heerspink HJL, Gao P, Zeeuw D, et al. The effect of ramipril and telmisartan on serum potassium and its association with cardiovascular and renal events: Results from the ONTARGET trial. Eur J Prev Cardiol 2014; 21:299-309.
    • (2014) Eur J Prev Cardiol , vol.21 , pp. 299-309
    • Hjl, H.1    Gao, P.2    Zeeuw, D.3
  • 36
    • 77949877308 scopus 로고    scopus 로고
    • Avosentan for overt diabetic nephro-pathy
    • Mann JFE, Green D, Jamerson K, et al. Avosentan for overt diabetic nephro-pathy. J Am Soc Nephrol 2010; 21:527-535.
    • (2010) J Am Soc Nephrol , vol.21 , pp. 527-535
    • Jfe, M.1    Green, D.2    Jamerson, K.3
  • 37
    • 42049107348 scopus 로고    scopus 로고
    • The ONTARGET Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events
    • The ONTARGET Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med 2008; 358:1547-1559.
    • (2008) N Engl J Med , vol.358 , pp. 1547-1559
  • 38
    • 84887467090 scopus 로고    scopus 로고
    • Combined angiotensin inhibition for the treatment of diabetic nephropathy
    • Fried LF, Emanuele N, Zhang JH, et al. Combined angiotensin inhibition for the treatment of diabetic nephropathy. N Engl J Med 2013; 369:1892-1903.
    • (2013) N Engl J Med , vol.369 , pp. 1892-1903
    • Fried, L.F.1    Emanuele, N.2    Zhang, J.H.3
  • 39
    • 77956284607 scopus 로고    scopus 로고
    • Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects
    • James WP, Caterson ID, Coutinho W, et al. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med 2010; 363:905-917.
    • (2010) N Engl J Med , vol.363 , pp. 905-917
    • James, W.P.1    Caterson, I.D.2    Coutinho, W.3
  • 40
    • 36348975228 scopus 로고    scopus 로고
    • Effects of torcetrapib in patients at high risk for coronary events
    • Barter PJ, Caulfield M, Eriksson M, et al. Effects of torcetrapib in patients at high risk for coronary events. N Engl J Med 2007; 357:2109-2122.
    • (2007) N Engl J Med , vol.357 , pp. 2109-2122
    • Barter, P.J.1    Caulfield, M.2    Eriksson, M.3
  • 41
    • 84927176250 scopus 로고    scopus 로고
    • A novel approach for establishing cardiovascular drug efficacy
    • Heerspink HJL, Grobbee DE, de Zeeuw D. A novel approach for establishing cardiovascular drug efficacy. Nat Rev Drug Discov 2014; 13:942.
    • (2014) Nat Rev Drug Discov , vol.13 , pp. 942
    • Hjl, H.1    Grobbee, D.E.2    De Zeeuw, D.3
  • 42
    • 84893805586 scopus 로고    scopus 로고
    • The importance of short-term off-target effects in estimating the long-term renal and cardiovascular protection of angiotensin receptor blockers
    • Smink PA, Miao Y, Eijkemans MJC, et al. The importance of short-term off-target effects in estimating the long-term renal and cardiovascular protection of angiotensin receptor blockers. Clin Pharmacol Ther 2014; 95:208-215.
    • (2014) Clin Pharmacol Ther , vol.95 , pp. 208-215
    • Smink, P.A.1    Miao, Y.2    Mjc, E.3
  • 43
    • 84942552333 scopus 로고    scopus 로고
    • The renal protective effect of angiotensin receptor blockers depends on intra-individual response variation in multiple risk markers
    • Epub ahead of print]
    • Schievink B, de Zeeuw D, Parving H, et al. The renal protective effect of angiotensin receptor blockers depends on intra-individual response variation in multiple risk markers. Br J Clin Pharmacol 2015; doi: 10.1111/bcp.12655. [Epub ahead of print]
    • (2015) Br J Clin Pharmacol
    • Schievink, B.1    De Zeeuw, D.2    Parving, H.3
  • 44
    • 84896465696 scopus 로고    scopus 로고
    • A prediction of the renal and cardiovascular efficacy of aliskiren in ALTITUDE using short-term changes in multiple risk markers
    • Smink P, Hoekman J, Grobbee D, et al. A prediction of the renal and cardiovascular efficacy of aliskiren in ALTITUDE using short-term changes in multiple risk markers. Eur J Prev Cardiol 2014; 21:434-441.
    • (2014) Eur J Prev Cardiol , vol.21 , pp. 434-441
    • Smink, P.1    Hoekman, J.2    Grobbee, D.3
  • 45
    • 80054724587 scopus 로고    scopus 로고
    • EuroKUP COST action. Urinary proteomics in the assessment of chronic kidney disease
    • Mullen W, Delles C, Mischak H. EuroKUP COST action. Urinary proteomics in the assessment of chronic kidney disease. Curr Opin Nephrol Hypertens 2011; 20:654-661.
    • (2011) Curr Opin Nephrol Hypertens , vol.20 , pp. 654-661
    • Mullen, W.1    Delles, C.2    Mischak, H.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.