KNOW-Ped CKD (KoreaN cohort study for outcomes in patients with pediatric CKD): Design and methods

Hee Gyung Kang, Hyun Jin Choi, Kyung Hee Han, Seong Heon Kim, Hee Yeon Cho, Min Hyun Cho, Jae Il Shin, Joo Hoon Lee, Joongyub Lee, Kook Hwan Oh, Young Seo Park, Hae Il Cheong, Curie Ahn, Il-Soo Ha, Hee Gyung Kang, Hyun Jin Choi, Kyung Hee Han, Seong Heon Kim, Hee Yeon Cho, Min Hyun Cho, Jae Il Shin, Joo Hoon Lee, Joongyub Lee, Kook Hwan Oh, Young Seo Park, Hae Il Cheong, Curie Ahn, Il-Soo Ha

Abstract

Background: The global prevalence of chronic kidney disease (CKD) is increasing. In children, CKD exhibits unique etiologies and can have serious impacts on children's growth and development. Therefore, an aggressive approach to preventing the progression of CKD and its complications is imperative. To improve the understanding and management of Asian pediatric patients with CKD, we designed and launched KNOW-Ped CKD (KoreaN cohort study for Outcome in patients With Pediatric Chronic Kidney Disease), a nationwide, prospective, and observational cohort study of pediatric CKD with funding from the Korean government.

Methods/design: From seven major centers, 450 patients <20 years of age with CKD stages I to V are recruited for the comprehensive assessment of clinical findings, structured follow-up, and bio-specimen collection. The primary endpoints include CKD progression, defined as a decline of estimated glomerular filtration rate by 50 %, and a requirement for renal replacement therapy or death. The secondary outcomes include the development of left ventricular hypertrophy or hypertension, impairment of growth, neuropsychological status, behavioral status, kidney growth, and quality of life.

Discussion: With this study, we expect to obtain more information on pediatric CKD, which can be translated to better management for the patients.

Trial registration: NCT02165878 (ClinicalTrials.gov), submitted on June 11, 2014.

Keywords: Asian children; Chronic kidney disease; Cohort study; Design; Prognostic factor.

References

    1. Kim S, Lim CS, Han DC, Kim GS, Chin HJ, Kim SJ, et al. 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. doi: 10.3346/jkms.2009.24.S1.S11.
    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):1296–305. doi: 10.1056/NEJMoa041031.
    1. Feldman HI, Appel LJ, Chertow GM, Cifelli D, Cizman B, Daugirdas J, et al. The Chronic Renal Insufficiency Cohort (CRIC) Study: design and methods. J Am Soc Nephrol. 2003;14(7 Suppl 2):S148–53. doi: 10.1097/01.ASN.0000070149.78399.CE.
    1. Imai E, Matsuo S, Makino H, Watanabe T, Akizawa T, Nitta K, et al. Chronic Kidney Disease Japan Cohort (CKD-JAC) study: design and methods. Hypertens Res. 2008;31(6):1101–7. doi: 10.1291/hypres.31.1101.
    1. Levin A, Rigatto C, Brendan B, Madore F, Muirhead N, Holmes D, et al. 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. Oh KH, Park SK, Park HC, Chin HJ, Chae DW, Choi KH, et al. KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease): design and methods. BMC Nephrol. 2014;15:80. doi: 10.1186/1471-2369-15-80.
    1. Nourbakhsh N, Rhee CM, Kalantar-Zadeh K. Protein-energy wasting and uremic failure to thrive in children with chronic kidney disease: they are not small adults. Pediatr Nephrol. 2014;29(12):2249–52. doi: 10.1007/s00467-014-2898-0.
    1. Mendley SR, Matheson MB, Shinnar S, Lande MB, Gerson AC, Butler RW, et al. Duration of chronic kidney disease reduces attention and executive function in pediatric patients. Kidney Int. 2015;87(4):800–6. doi: 10.1038/ki.2014.323.
    1. Furth SL, Abraham AG, Jerry-Fluker J, Schwartz GJ, Benfield M, Kaskel F, et al. Metabolic abnormalities, cardiovascular disease risk factors, and GFR decline in children with chronic kidney disease. Clin J Am Soc Nephrol. 2011;6(9):2132–40. doi: 10.2215/CJN.07100810.
    1. Querfeld U, Anarat A, Bayazit AK, Bakkaloglu AS, Bilginer Y, Caliskan S, et al. The Cardiovascular Comorbidity in Children with Chronic Kidney Disease (4C) Study: objectives, design, and methodology. Clin J Am Soc Nephrol. 2010;5(9):1642–8. doi: 10.2215/CJN.08791209.
    1. Mencarelli F, Fabi M, Corazzi V, Doyon A, Masetti R, Bonetti S, et al. Left ventricular mass and cardiac function in a population of children with chronic kidney disease. Pediatr Nephrol. 2014;29(5):893–900. doi: 10.1007/s00467-013-2710-6.
    1. Greenbaum LA, Warady BA, Furth SL. Current advances in chronic kidney disease in children: growth, cardiovascular, and neurocognitive risk factors. Sem Nephrol. 2009;29(4):425–34. doi: 10.1016/j.semnephrol.2009.03.017.
    1. Tsampalieros A, Kalkwarf HJ, Wetzsteon RJ, Shults J, Zemel BS, Foster BJ, et al. Changes in bone structure and the muscle-bone unit in children with chronic kidney disease. Kidney Int. 2013;83(3):495–502. doi: 10.1038/ki.2012.347.
    1. Rodig NM, McDermott KC, Schneider MF, Hotchkiss HM, Yadin O, Seikaly MG, et al. Growth in children with chronic kidney disease: a report from the Chronic Kidney Disease in Children Study. Pediatr Nephrol. 2014;29(10):1987–95. doi: 10.1007/s00467-014-2812-9.
    1. Furth SL, Cole SR, Moxey-Mims M, Kaskel F, Mak R, Schwartz G, et al. Design and methods of the Chronic Kidney Disease in Children (CKiD) prospective cohort study. Clin J Am Soc Nephrol. 2006;1(5):1006–15. doi: 10.2215/CJN.01941205.
    1. Ardissino G, Dacco V, Testa S, Bonaudo R, Claris-Appiani A, Taioli E, et al. Epidemiology of chronic renal failure in children: data from the ItalKid project. Pediatrics. 2003;111(4 Pt 1):e382–7. doi: 10.1542/peds.111.4.e382.
    1. Boehm M, Riesenhuber A, Winkelmayer WC, Arbeiter K, Mueller T, Aufricht C. Early erythropoietin therapy is associated with improved growth in children with chronic kidney disease. Pediatr Nephrol. 2007;22(8):1189–93. doi: 10.1007/s00467-007-0472-8.
    1. Seikaly MG, Salhab N, Warady BA, Stablein D. Use of rhGH in children with chronic kidney disease: lessons from NAPRTCS. Pediatr Nephrol. 2007;22(8):1195–204. doi: 10.1007/s00467-007-0497-z.
    1. Soares CMB, Diniz JSS, Lima EM, Silva JMP, Oliveira GR, Canhestro MR, et al. Clinical outcome of children with chronic kidney disease in a pre-dialysis interdisciplinary program. Pediatr Nephrol. 2008;23(11):2039–46. doi: 10.1007/s00467-008-0868-0.
    1. Staples AO, Greenbaum LA, Smith JM, Gipson DS, Filler G, Warady BA, et al. Association between clinical risk factors and progression of chronic kidney disease in children. Clin J Am Soc Nephrol. 2010;5(12):2172–9. doi: 10.2215/CJN.07851109.
    1. Seikaly MG, Ho PL, Emmett L, Fine RN, Tejani A. Chronic renal insufficiency in children: the 2001 Annual Report of the NAPRTCS. Pediatr Nephrol. 2003;18(8):796–804. doi: 10.1007/s00467-003-1158-5.
    1. Warady BA, Abraham AG, Schwartz GJ, Wong CS, Munoz A, Betoko A, et al. Predictors of rapid progression of glomerular and nonglomerular kidney disease in children and adolescents: The Chronic Kidney Disease in Children (CKiD) Cohort. Am J Kidney Dis. 2015;65(6):878–88. doi: 10.1053/j.ajkd.2015.01.008.
    1. Trapote RA, Ibanez MJS, Navarro M, Repir II. Epidemiology of chronic kidney disease in the Spanish paediatric population. REPIR II Project. Nefrologia. 2010;30(5):508–17.
    1. Ishikura K, Uemura O, Ito S, Wada N, Hattori M, Ohashi Y, et al. Pre-dialysis chronic kidney disease in children: results of a nationwide survey in Japan. Nephrol Dial Transplant. 2013;28(9):2345–55. doi: 10.1093/ndt/gfs611.
    1. Eknoyan G, Levin NW. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002;39(2 Suppl 1):S1–266.
    1. International Society of Nephrology Chapter 1: definition and classification of CKD. Kidney Int Suppl. 2013;3(1):19–62. doi: 10.1038/kisup.2012.64.
    1. Fadrowski JJ, Neu AM, Schwartz GJ, Furth SL. Pediatric GFR estimating equations applied to adolescents in the general population. Clin J Am Soc Nephrol. 2011;6(6):1427–35. doi: 10.2215/CJN.06460710.
    1. Piepsz A, Tondeur M, Ham H. Revisiting normal (51)Cr-ethylenediaminetetraacetic acid clearance values in children. Eur J Nucl Med Mol Imaging. 2006;33(12):1477–82. doi: 10.1007/s00259-006-0179-2.
    1. Pottel H, Mottaghy FM, Zaman Z, Martens F. On the relationship between glomerular filtration rate and serum creatinine in children. Pediatr Nephrol. 2010;25(5):927–34. doi: 10.1007/s00467-009-1389-1.
    1. Kweon S, Kim Y, Jang MJ, Kim Y, Kim K, Choi S, et al. Data resource profile: the Korea National Health and Nutrition Examination Survey (KNHANES) Int J Epidemiol. 2014;43(1):69–77. doi: 10.1093/ije/dyt228.
    1. Sanusi AA, Arogundade FA, Famurewa OC, Akintomide AO, Soyinka FO, Ojo OE, et al. Relationship of ultrasonographically determined kidney volume with measured GFR, calculated creatinine clearance and other parameters in Chronic Kidney Disease (CKD) Nephrol Dial Transplant. 2009;24(5):1690–4. doi: 10.1093/ndt/gfp055.
    1. Pottel H, Hoste L, Martens F. A simple height-independent equation for estimating glomerular filtration rate in children. Pediatr Nephrol. 2012;27(6):973–9. doi: 10.1007/s00467-011-2081-9.
    1. Chae PK, Jung HO, Noh KS. Attention deficit hyperactivty disorder in Korean juvenile delinquents. Adolescence. 2001;36(144):707–25.
    1. Biederman J, Spencer T, Lomedico A, Day H, Petty CR, Faraone SV. Deficient emotional self-regulation and pediatric attention deficit hyperactivity disorder: a family risk analysis. Psychol Med. 2012;42(3):639–46. doi: 10.1017/S0033291711001644.
    1. Magnusson P, Smari J, Gretarsdottir H, Prandardottir H. Attention-deficit/hyperactivity symptoms in icelandic schoolchildren: assessment with the attention deficit/hyperactivity rating scale-IV. Scand J Psychol. 1999;40(4):301–6. doi: 10.1111/1467-9450.404130.
    1. Kendall PC, Finch AJ, Jr, Auerbach SM, Hooke JF, Mikulka PJ. The State-Trait Anxiety Inventory: a systematic evaluation. J Consult Clin Psychol. 1976;44(3):406–12. doi: 10.1037/0022-006X.44.3.406.
    1. Finch AJ, Jr, Saylor CF, Edwards GL. Children’s depression inventory: sex and grade norms for normal children. J Consult Clin Psychol. 1985;53(3):424–5. doi: 10.1037/0022-006X.53.3.424.
    1. Wilhelm K, Niven H, Parker G, Hadzi-Pavlovic D. The stability of the parental bonding instrument over a 20-year period. Psychol Med. 2005;35(3):387–93. doi: 10.1017/S0033291704003538.
    1. Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999;37(2):126–39. doi: 10.1097/00005650-199902000-00003.
    1. Kook SH, Varni JW. Validation of the Korean version of the pediatric quality of life inventory 4.0 (PedsQL) generic core scales in school children and adolescents using the Rasch model. Health Qual Life Outcomes. 2008;6:41. doi: 10.1186/1477-7525-6-41.
    1. Lau B, Cole SR, Gange SJ. Competing risk regression models for epidemiologic data. Am J Epidemiol. 2009;170(2):244–56. doi: 10.1093/aje/kwp107.
    1. Lin CY, Sheng CC, Chen CH, Lin CC, Chou P. The prevalence of heavy proteinuria and progression risk factors in children undergoing urinary screening. Pediatr Nephrol. 2000;14(10-11):953–9. doi: 10.1007/s004679900278.
    1. Ishikura K, Uemura O, Hamasaki Y, Ito S, Wada N, Hattori M, et al. Progression to end-stage kidney disease in Japanese children with chronic kidney disease: results of a nationwide prospective cohort study. Nephrol Dial Transplant. 2014;29(4):878–84. doi: 10.1093/ndt/gfu012.
    1. Yap HK, Quek CM, Shen Q, Joshi V, Chia KS. Role of urinary screening programmes in children in the prevention of chronic kidney disease. Ann Acad Med Singapore. 2005;34(1):3–7.
    1. Park YH, Choi JY, Chung HS, Koo JW, Kim SY, Namgoong MK, et al. Hematuria and proteinuria in a mass school urine screening test. Pediatr Nephrol. 2005;20(8):1126–30. doi: 10.1007/s00467-005-1915-8.
    1. Murakami M, Hayakawa M, Yanagihara T, Hukunaga Y. Proteinuria screening for children. Kidney Int Suppl. 2005;94:S23–7. doi: 10.1111/j.1523-1755.2005.09406.x.
    1. Lin CY, Sheng CC, Lin CC, Chen CH, Chou P. Mass urinary screening and follow-up for school children in Taiwan Province. Acta Paediatr Taiwan. 2001;42(3):134–40.
    1. Kitagawa T. Lessons learned from the Japanese nephritis screening study. Pediatr Nephrol. 1988;2(2):256–63. doi: 10.1007/BF00862602.
    1. Yang H, Wang Q, Luo J, Li Q, Wang L, Li CC, et al. Ultrasound of urinary system and urinary screening in 14 256 asymptomatic children in China. Nephrology (Carlton) 2010;15(3):362–7. doi: 10.1111/j.1440-1797.2009.01262.x.
    1. Wong CS, Pierce CB, Cole SR, Warady BA, Mak RHK, Benador NM, et al. Association of Proteinuria with Race, Cause of Chronic Kidney Disease, and Glomerular Filtration Rate in the Chronic Kidney Disease in Children Study. Clin J Am Soc Nephrol. 2009;4(4):812–9. doi: 10.2215/CJN.01780408.
    1. Health Insurance Review and Assessment Service of Korea. Disease Statistics according to ICD-10 code [] 2014.
    1. National Kidney F. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002;39(2 Suppl 1):S1–266.
    1. Hunley TE, Kon V, Ichikawa I. Glomerular circulation and function. In: Avner ED, Harmon WE, Niaude P, Yoshikawa N, editors. Pediatric nephrology. 6. Berlin: Springer; 2009. pp. 31–64.
    1. Wong CJ, Moxey-Mims M, Jerry-Fluker J, Warady BA, Furth SL. CKiD (CKD in children) prospective cohort study: a review of current findings. Am J Kidney Dis. 2012;60(6):1002–11. doi: 10.1053/j.ajkd.2012.07.018.

Source: PubMed

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구독하다