KNOW-KT (KoreaN cohort study for outcome in patients with kidney transplantation: a 9-year longitudinal cohort study): study rationale and methodology

BMC Nephrology

Curie Ahn⁷  Yu Seun Kim¹  Sung Joo Kim⁹  Chan-Duck Kim⁴  Sung Kwang Park^1,10  Wookyung Chung²  Sung-Bae Park⁸  Duck Jong Han⁶  Byung-Joo Park⁵  Jong Cheol Jeong³  Young Hoon Kim⁶  Seung-Yeup Han⁸  Han Ro²  Sik Lee^1,10  Jang-Hee Cho⁴  Jae Berm Park⁹  Kyu Ha Huh¹  Joongyup Lee⁵  Jaeseok Yang³ 

[1] Department of Transplantation Surgery, Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea;Department of Internal Medicine, Gachon University, Gil Hospital, Seoul, Republic of Korea;Transplantation Center, Seoul National University Hospital, Seoul, Republic of Korea;Department of Internal Medicine, Kyungpook National University Hospital, Seoul, Republic of Korea;Medical Research Collaborating Center, Seoul National University Hospital, Seoul, Republic of Korea;Department of Surgery, Ulsan University, Seoul Asan Medical Center, Seoul, Republic of Korea;Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea;Department of Internal Medicine, Keimyung University, Dongsan Medical Center, Seoul, Republic of Korea;Department of Surgery, Sungkyunkwan University, Seoul Samsung Medical Center, Seoul, Republic of Korea;Department of Internal Medicine, Chonbuk National University Hospital, Seoul, Republic of Korea

关键词: Risk factor;    KNOW-KT;    Kidney transplantation;    Complication;    Cohort study;   

Others  :  1082685
DOI  :  10.1186/1471-2369-15-77

 received in 2014-04-02, accepted in 2014-04-16,  发布年份 2014

【 摘 要 】

Background

Asian patients undergoing kidney transplantation (KT) generally have better renal allograft survival and a lower burden of cardiovascular disease than those of other racial groups. The KNOW-KT aims to explore allograft survival rate, cardiovascular events, and metabolic profiles and to elucidate the risk factors in Korean KT patients.

Methods

KNOW-KT is a multicenter, observational cohort study encompassing 8 transplant centers in the Republic of Korea. KNOW-KT will enroll 1,000 KT recipients between 2012 and 2015 and follow them up to 9 years. At the time of KT and at pre-specified intervals, clinical information, laboratory test results, and functional and imaging studies on cardiovascular disease and metabolic complications will be recorded. Comorbid status will be assessed by the age-adjusted Charlson co-morbidity index. Medication adherence and information on quality of life (QoL) will be monitored periodically. The QoL will be assessed by the Kidney Disease Quality of Life Short Form. Donors will include both living donors and deceased donors whose status will be assessed by the Kidney Donor Risk Index. Primary endpoints include graft loss and patient mortality. Secondary endpoints include renal functional deterioration (a decrease in eGFR to <30 mL/min/1.73 m²), acute rejection, cardiovascular event, albuminuria, new-onset diabetes after transplant, and QoL. Data on other adverse outcomes including episodes of infection, malignancy, recurrence of original renal disease, fracture, and hospitalization will also be collected. A bio-bank has been established for the acquisition of DNA, RNA, and protein from serum and urine samples of recipients at regular intervals. Bio-samples from donors will also be collected at the time of KT. KNOW-KT was registered in an international clinical trial registry (NCT02042963 at http://www.clinicaltrials.gov webcite) on January 20^th, 2014.

Conclusion

The KNOW-KT, the first large-scale cohort study in Asian KT patients, is expected to represent the Asian KT population and provide information on their natural course, complications, and risk factors for complications.

【 授权许可】

   
2014 Yang et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Liu J, Hong Y, D'Agostino RB Sr, Wu Z, Wang W, Sun J, Wilson PW, Kannel WB, Zhao D: Predictive value for the Chinese population of the Framingham CHD risk assessment tool compared with the Chinese Multi-Provincial Cohort Study. JAMA 2004, 291(21):2591-2599.
• [2]Jeong JC, Ro H, Hwang YH, Lee HK, Ha J, Ahn C, Yang J: Cardiovascular diseases after kidney transplantation in Korea. J Kor Med Sci 2010, 25(11):1589-1594.
• [3]Jin DC, Han JS: Renal replacment therpay in Korea, 2012. Kidney Res Clin Pract 2014, 33(1):9-18.
• [4]Samaan F, Requiao-Moura LR, Pinheiro HS, Ozaki KS, Saraiva Camara NO, Pacheco-Silva A: Prevalence and progression of chronic kidney disease after renal transplantation. Transplant Proc 2011, 43(7):2587-2591.
• [5]Fernandez-Fresnedo G, de Francisco A, Ruiz JC, Cotorruelo JG, Alamillo CG, Valero R, Castaneda O, Zalduendo B, Izquierdo MJ, Arias M: Relevance of chronic kidney disease classification (K/DOQI) in renal transplant patients. Transplant Proc 2006, 38(8):2402-2403.
• [6]Kasiske BL, Israni AK, Snyder JJ, Camarena A, Investigators C: Design considerations and feasibility for a clinical trial to examine coronary screening before kidney transplantation (COST). Am J Kid Dis 2011, 57(6):908-916.
• [7]Matas AJ, Leduc R, Rush D, Cecka JM, Connett J, Fieberg A, Halloran P, Hunsicker L, Cosio F, Grande J, Mannon R, Gourishankar S, Gaston R, Kasiske B: Histopathologic clusters differentiate subgroups within the nonspecific diagnoses of CAN or CR: preliminary data from the DeKAF study. Am J Transplant 2010, 10(2):315-323.
• [8]Shao P, Tang L, Li P, Xu Y, Qin C, Cao Q, Ju X, Meng X, Lv Q, Li J, Zhang W, Yin C: Application of a vasculature model and standardization of the renal hilar approach in laparoscopic partial nephrectomy for precise segmental artery clamping. Eur Urol 2013, 63(6):1072-1081.
• [9]Georg Y, Schwein A, Lejay A, Tartaglia E, Girsowicz E, Kretz JG, Thaveau F, Chakfe N: Practical experience with the TAG and conformable TAG devices: lessons learned in about 100 cases. J Cardiovasc Surg 2013, 54(5):605-615.
• [10]Charlson M, Szatrowski TP, Peterson J, Gold J: Validation of a combined comorbidity index. J Clin Epidemiol 1994, 47(11):1245-1251.
• [11]Molnar-Varga M, Molnar MZ, Szeifert L, Kovacs AZ, Kelemen A, Becze A, Laszlo G, Szentkiralyi A, Czira ME, Mucsi I, Novak M: Health-related quality of life and clinical outcomes in kidney transplant recipients. Am J Kid Dis 2011, 58(3):444-452.
• [12]Han M, Jeong JC, Koo TY, Jeon HJ, Kwon HY, Kim YJ, Ryu HJ, Ahn C, Yang J: Kidney donor risk index is a good prognostic tool for graft outcomes in deceased donor kidney transplantation with short, cold ischemic time. Clin Transpl 2014, 28(3):337-344.
• [13]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.
• [14]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.
• [15]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 Kid Dis 2012, 59(4):504-512.
• [16]Crainiceanu CM, Ruppert D, Wand MP: Bayesian analysis for penalized spline regression using WinBUGS. J Stat Softw 2005, 14(14):1-24.
• [17]Valdes-Canedo F, Pita-Fernandez S, Seijo-Bestilleiro R, Pertega-Diaz S, Alonso-Hernandez A, Cillero-Rego S, Fernandez-Rivera C, Oliver-Garcia J: Incidence of cardiovascular events in renal transplant recipients and clinical relevance of modifiable variables. Transplant Proc 2007, 39(7):2239-2241.
• [18]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.
• [19]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.
• [20]Mok CC: Racial difference in the prognosis of lupus nephritis. Nephrology (Carlton) 2010, 15(4):480-481.
• [21]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.
• [22]Fan PY, Ashby VB, Fuller DS, Boulware LE, Kao A, Norman SP, Randall HB, Young C, Kalbfleisch JD, Leichtman AB: Access and outcomes among minority transplant patients, 1999–2008, with a focus on determinants of kidney graft survival. Am J Transplant 2010, 10(4 Pt 2):1090-1107.
• [23]Katznelson S, Gjertson DW, Cecka JM: The effect of race and ethnicity on kidney allograft outcome. Clin Transpl 1995, 379-394.
• [24]Kasiske BL, Snyder JJ, Gilbertson DT, Wang C: Cancer after kidney transplantation in the United States. Am J Transplant 2004, 4(6):905-913.
• [25]Opelz G, Dohler B, Ruhenstroth A, Cinca S, Unterrainer C, Stricker L, Scherer S, Gombos P, Susal C, Daniel V, Tran H: The collaborative transplant study registry. Transplantat Rev 2013, 27(2):43-45.
• [26]Annual Data Report of the US Organ Procurement and Transplantation Network (OPTN) and the Scientific Registry of Transplant Recipients (SRTR). Introduction Am J Ttransplant 2013, 13(Suppl 1):8-10.
• [27]Gray NA, Mahadevan K, Campbell VK, Noble EP, Anstey CM: Data quality of the Australia and New Zealand Dialysis and Transplant Registry: a pilot audit. Nephrology (Carlton) 2013, 18(10):665-670.