KNOW-KT（韩国肾移植患者结局队列研究：一项为期 9 年的纵向队列研究）：研究背景与方法。

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

机构信息

Transplantation Center, Seoul National University Hospital, Seoul, Republic of Korea.

出版信息

BMC Nephrol. 2014 May 9;15:77. doi: 10.1186/1471-2369-15-77.

DOI:10.1186/1471-2369-15-77

PMID:24884405

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4022441/

Abstract

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) on January 20th, 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.

摘要

背景

亚洲接受肾移植（KT）的患者的肾移植存活率一般优于其他种族群体，且心血管疾病负担较低。 KNOW-KT 旨在探索韩国 KT 患者的移植物存活率、心血管事件和代谢谱，并阐明其危险因素。

方法

KNOW-KT 是一项多中心、观察性队列研究，涵盖了韩国 8 个移植中心。KNOW-KT 将在 2012 年至 2015 年期间招募 1000 名 KT 受者，并对其进行 9 年的随访。在 KT 时以及在预先指定的时间间隔内，将记录临床信息、实验室检查结果以及心血管疾病和代谢并发症的功能和影像学研究。合并症状态将通过年龄调整的 Charlson 合并症指数进行评估。定期监测药物依从性和生活质量（QoL）信息。QoL 将通过肾脏病生活质量简表进行评估。供体包括活体供体和已故供体，其状态将通过肾脏供体风险指数进行评估。主要终点包括移植物丢失和患者死亡。次要终点包括肾功能恶化（eGFR 下降至<30ml/min/1.73m2）、急性排斥反应、心血管事件、白蛋白尿、移植后新发糖尿病和 QoL。还将收集其他不良结局的数据，包括感染、恶性肿瘤、原肾疾病复发、骨折和住院。还为定期从受者的血清和尿液样本中获取 DNA、RNA 和蛋白质建立了生物库。在 KT 时还将收集供体的生物样本。KNOW-KT 于 2014 年 1 月 20 日在国际临床试验注册处（NCT02042963，http://www.clinicaltrials.gov）注册。