KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease): design and methods

Kook-Hwan Oh, Sue Kyung Park, Hayne Cho Park, Ho Jun Chin, Dong Wan Chae, Kyu Hun Choi, Seung Hyeok Han, Tae Hyun Yoo, Kyubeck Lee, Yong-Soo Kim, Wookyung Chung, Young-Hwan Hwang, Soo Wan Kim, Yeong Hoon Kim, Sun Woo Kang, Byung-Joo Park, Joongyub Lee, Curie Ahn, Representing KNOW-CKD Study Group, Curie Ahn, Kook-Hwan Oh, Dong Wan Chae, Ho Jun Chin, Hayne Cho Park, Seungmi Lee, Hyun Hwa Jang, Hyun Jin Cho, Kyu Hun Choi, Seung Hyeok Han, Tae Hyun Yoo, Mi Hyun Yu, Kyubeck Lee, Sooyeon Jin, Yong-Soo Kim, Sol Ji Kim, Wookyung Chung, Youkyoung Jang, Ji Hye Park, Young-Hwan Hwang, Su-Ah Sung, Jeong Ok So, Soo Wan Kim, Ji Seon Lee, Yeong Hoon Kim, Sun Woo Kang, Yun Jin Kim, Byung-Joo Park, Sue Kyung Park, Juyeon Lee, Joongyub Lee, Dayeon Nam, Soohee Kang, Heejung Ahn, Donghee Seo, Dae Yeon Cho, Dukhyoung Lee, Hyekyung Park, Suyeon Jeong, Eunmi Ahn, Sil-Hea Sung, Kook-Hwan Oh, Sue Kyung Park, Hayne Cho Park, Ho Jun Chin, Dong Wan Chae, Kyu Hun Choi, Seung Hyeok Han, Tae Hyun Yoo, Kyubeck Lee, Yong-Soo Kim, Wookyung Chung, Young-Hwan Hwang, Soo Wan Kim, Yeong Hoon Kim, Sun Woo Kang, Byung-Joo Park, Joongyub Lee, Curie Ahn, Representing KNOW-CKD Study Group, Curie Ahn, Kook-Hwan Oh, Dong Wan Chae, Ho Jun Chin, Hayne Cho Park, Seungmi Lee, Hyun Hwa Jang, Hyun Jin Cho, Kyu Hun Choi, Seung Hyeok Han, Tae Hyun Yoo, Mi Hyun Yu, Kyubeck Lee, Sooyeon Jin, Yong-Soo Kim, Sol Ji Kim, Wookyung Chung, Youkyoung Jang, Ji Hye Park, Young-Hwan Hwang, Su-Ah Sung, Jeong Ok So, Soo Wan Kim, Ji Seon Lee, Yeong Hoon Kim, Sun Woo Kang, Yun Jin Kim, Byung-Joo Park, Sue Kyung Park, Juyeon Lee, Joongyub Lee, Dayeon Nam, Soohee Kang, Heejung Ahn, Donghee Seo, Dae Yeon Cho, Dukhyoung Lee, Hyekyung Park, Suyeon Jeong, Eunmi Ahn, Sil-Hea Sung

Abstract

Background: The progression and complications of chronic kidney disease should differ depending on the cause (C), glomerular filtration rate category (G), and albuminuria (A). The KNOW-CKD (KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease), which is a prospective cohort study, enrolls subjects with chronic kidney disease stages 1 to 5 (predialysis).

Methods/design: Nine nephrology centers in major university hospitals throughout Korea will enroll approximately 2,450 adults with chronic kidney disease over a 5-year period from 2011 to 2015. The participating individuals will be monitored for approximately 10 years until death or until end-stage renal disease occurs. The subjects will be classified into subgroups based on the following specific causes of chronic kidney disease: glomerulonephritis, diabetic nephropathy, hypertensive nephropathy, polycystic kidney disease, and others. The eligible subjects will be evaluated at baseline for socio-demographic information, detailed personal/family history, office BP, quality of life, and health behaviors. After enrollment in the study, thorough assessments, including laboratory tests, cardiac evaluation and radiologic imaging, will be performed according to the standardized protocol. The biospecimen samples will be collected regularly. A renal event is defined by >50% decrease in estimated GFR (eGFR) from the baseline values, doubling of serum creatinine, or end-stage renal disease. The primary composite outcome consists of renal events, cardiovascular events, and death. As of September 2013, 1,470 adult chronic kidney disease subjects were enrolled in the study, including 543 subjects with glomerulonephritis, 317 with diabetic nephropathy, 294 with hypertensive nephropathy and 249 with polycystic kidney disease.

Discussion: As the first large-scale chronic kidney disease cohort study to be established and maintained longitudinally for up to 10 years, the KNOW-CKD will help to clarify the natural course, complication profiles, and risk factors of Asian populations with chronic kidney disease.

Trial registration: No. NCT01630486 at http://www.clinicaltrials.gov.

Figures

Figure 1
Figure 1
Age-adjusted modified Charlson comorbidity index in total and subgroup participants, KNOW-CKD 2011–2013. Abbreviations: GN, glomerulonephritis; DN, diabetic nephropathy; HTN, hypertensive nephropathy; PKD, polycystic kidney disease.

References

    1. Kim S, Lim CS, Han DC, Kim GS, Chin HJ, Kim SJ, Cho WY, Kim YH, Kim YS. The prevalence of chronic kidney disease (CKD) and the associated factors to CKD in urban Korea: a population-based cross-sectional epidemiologic study. J Korean Med Sci. 2009;24(Suppl):S11–21.
    1. Anavekar NS, McMurray JJ, Velazquez EJ, Solomon SD, Kober L, Rouleau JL, White HD, Nordlander R, Maggioni A, Dickstein K, Zelenkofske S, Leimberger JD, Califf RM, Pfeffer MA. Relation between renal dysfunction and cardiovascular outcomes after myocardial infarction. N Engl J Med. 2004;351(13):1285–1295. doi: 10.1056/NEJMoa041365.
    1. Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004;351(13):1296–1305. doi: 10.1056/NEJMoa041031.
    1. Astor BC, Matsushita K, Gansevoort RT, van der Velde M, Woodward M, Levey AS, de Jong PE, Coresh J, El-Nahas M, Eckardt KU, Kasiske BL, Wright J, Appel L, Greene T, Levin A, Djurdjev O, Wheeler DC, Landray MJ, Townend JN, Emberson J, Clark LE, Macleod A, Marks A, Ali T, Fluck N, Prescott G, Smith DH, Weinstein JR, Johnson ES, Thorp ML. et al.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. 2011;79(12):1331–1340. doi: 10.1038/ki.2010.550.
    1. Gansevoort RT, Matsushita K, van der Velde M, Astor BC, Woodward M, Levey AS, de Jong PE, Coresh J. 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. 2011;80(1):93–104. doi: 10.1038/ki.2010.531.
    1. Levey AS, de Jong PE, Coresh J, El Nahas M, Astor BC, Matsushita K, Gansevoort RT, Kasiske BL, Eckardt KU. The definition, classification, and prognosis of chronic kidney disease: a KDIGO Controversies Conference report. Kidney Int. 2011;80(1):17–28. doi: 10.1038/ki.2010.483.
    1. Stevens PE, Levin A. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013;158(11):825–830. doi: 10.7326/0003-4819-158-11-201306040-00007.
    1. Feldman HI, Appel LJ, Chertow GM, Cifelli D, Cizman B, Daugirdas J, Fink JC, Franklin-Becker ED, Go AS, Hamm LL, He J, Hostetter T, Hsu CY, Jamerson K, Joffe M, Kusek JW, Landis JR, Lash JP, Miller ER, 3rd Mohler ER, Muntner P, Ojo AO, Rahman M, Townsend RR, Wright JT. Chronic Renal Insufficiency Cohort (CRIC) Study Investigators. The Chronic Renal Insufficiency Cohort (CRIC) Study: Design and Methods. J Am Soc Nephrol. 2003;14(7 Suppl 2):S148–153.
    1. Lash JP, Go AS, Appel LJ, He J, Ojo A, Rahman M, Townsend RR, Xie D, Cifelli D, Cohan J, Fink JC, Fischer MJ, Gadegbeku C, Hamm LL, Kusek JW, Landis JR, Narva A, Robinson N, Teal V, Feldman HI. Chronic Renal Insufficiency Cohort (CRIC) Study Group. Chronic Renal Insufficiency Cohort (CRIC) Study: baseline characteristics and associations with kidney function. Clin J Am Soc Nephrol. 2009;4(8):1302–1311. doi: 10.2215/CJN.00070109.
    1. Imai E, Matsuo S, Makino H, Watanabe T, Akizawa T, Nitta K, Iimuro S, Ohashi Y, Hishida A. Chronic Kidney Disease Japan Cohort (CKD-JAC) study: design and methods. Hypertens Res. 2008;31(6):1101–1107. doi: 10.1291/hypres.31.1101.
    1. Levin A, Rigatto C, Brendan B, Madore F, Muirhead N, Holmes D, Clase CM, Tang M, Djurdjev O, Can P. Cohort profile: Canadian study of prediction of death, dialysis and interim cardiovascular events (CanPREDDICT) BMC Nephrol. 2013;14:121. doi: 10.1186/1471-2369-14-121.
    1. Levey AS, Coresh J, Greene T, Stevens LA, Zhang YL, Hendriksen S, Kusek JW, Van Lente F. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med. 2006;145(4):247–254. doi: 10.7326/0003-4819-145-4-200608150-00004.
    1. Belibi FA, Edelstein CL. Unified ultrasonographic diagnostic criteria for polycystic kidney disease. J Am Soc Nephrol. 2009;20(1):6–8. doi: 10.1681/ASN.2008111164.
    1. Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J. CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009;150(9):604–612. doi: 10.7326/0003-4819-150-9-200905050-00006.
    1. Inker LA, Schmid CH, Tighiouart H, Eckfeldt JH, Feldman HI, Greene T, Kusek JW, Manzi J, Van Lente F, Zhang YL, Coresh J, Levey AS. CKD-EPI Investigators. Estimating glomerular filtration rate from serum creatinine and cystatin C. N Engl J Med. 2012;367(1):20–29. doi: 10.1056/NEJMoa1114248.
    1. Grubb A, Blirup-Jensen S, Lindstrom V, Schmidt C, Althaus H, Zegers I. First certified reference material for cystatin C in human serum ERM-DA471/IFCC. Clin Chem Lab Med. 2010;48(11):1619–1621.
    1. Blirup-Jensen S, Grubb A, Lindstrom V, Schmidt C, Althaus H. Standardization of Cystatin C: development of primary and secondary reference preparations. Scand J Clin Lab Invest Suppl. 2008;241:67–70.
    1. Hoefield RA, Kalra PA, Baker P, Lane B, New JP, O'Donoghue DJ, Foley RN, Middleton RJ. Factors associated with kidney disease progression and mortality in a referred CKD population. Am J Kidney Dis. 2010;56(6):1072–1081. doi: 10.1053/j.ajkd.2010.06.010.
    1. Ratcliffe SJ, Guo W, Ten Have TR. Joint modeling of longitudinal and survival data via a common frailty. Biometrics. 2004;60(4):892–899. doi: 10.1111/j.0006-341X.2004.00244.x.
    1. Li L, Astor BC, Lewis J, Hu B, Appel LJ, Lipkowitz MS, Toto RD, Wang X, Wright JT Jr, Greene TH. Longitudinal progression trajectory of GFR among patients with CKD. Am J Kidney Dis. 2012;59(4):504–512. doi: 10.1053/j.ajkd.2011.12.009.
    1. Crainiceanu CM, Ruppert D, Wand MP. Bayesian analysis for penalized spline regression using WinBUGS. J Stat Softw. 2005;14(14)
    1. Nagata M, Ninomiya T, Doi Y, Yonemoto K, Kubo M, Hata J, Tsuruya K, Iida M, Kiyohara Y. Trends in the prevalence of chronic kidney disease and its risk factors in a general Japanese population: the Hisayama Study. Nephrol Dial Transplant. 2010;25(8):2557–2564. doi: 10.1093/ndt/gfq062.
    1. Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007;298(17):2038–2047. doi: 10.1001/jama.298.17.2038.
    1. Matsushita K, van der Velde M, Astor BC, Woodward M, Levey AS, de Jong PE, Coresh J, Gansevoort RT. Association of estimated glomerular filtration rate and albuminuria with all-cause and cardiovascular mortality in general population cohorts: a collaborative meta-analysis. Lancet. 2010;375(9731):2073–2081.
    1. Mehrotra R, Kermah D, Fried L, Adler S, Norris K. Racial differences in mortality among those with CKD. J Am Soc Nephrol. 2008;19(7):1403–1410. doi: 10.1681/ASN.2007070747.
    1. Muntner P, Newsome B, Kramer H, Peralta CA, Kim Y, Jacobs DR Jr, Kiefe CI, Lewis CE. Racial differences in the incidence of chronic kidney disease. Clin J Am Soc Nephrol. 2012;7(1):101–107. doi: 10.2215/CJN.06450611.
    1. Mok CC. Racial difference in the prognosis of lupus nephritis. Nephrology (Carlton) 2010;15(4):480–481. doi: 10.1111/j.1440-1797.2010.01318.x.
    1. Jovanovich A, Chonchol M, Cheung AK, Kaufman JS, Greene T, Roberts WL, Smits G, Kendrick J. Racial differences in markers of mineral metabolism in advanced chronic kidney disease. Clin J Am Soc Nephrol. 2012;7(4):640–647. doi: 10.2215/CJN.07020711.
    1. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999;130(6):461–470. doi: 10.7326/0003-4819-130-6-199903160-00002.

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