C-INSIGHT: design and methodology of a nationwide registry for high-risk chronic kidney disease in China – a study protocol
Year: 2025
Type: conference-abstract
Study design: Study Protocol
Abstract: BACKGROUND: Chronic kidney disease (CKD) poses a significant global health challenge due to its high prevalence, low awareness, poor prognosis, and substantial medical costs. High-risk factors such as severe proteinuria and hypertension exacerbate CKD progression, leading to adverse kidney outcomes, cardiovascular diseases, hospitalizations, and increased mortality. Despite existing CKD registries in China, comprehensive data on patients at high-risk of CKD progression, such as patient with CKD and high proteinuria (CKD-HP) or hypertension (CKD-HTN) are lacking, highlighting the need for a dedicated registry to amass comprehensive patient data, thereby enhancing disease understanding. METHODS: The China Chronic Kidney Disease Registry Platform Study (C-INSIGHT) is a national-wide, multicenter, prospective, observational study designed to enroll approximately 5,000 patients at high risk of CKD progression, including severe proteinuria (urine albumin-to-creatinine ratios (UACR) ≥ 700 mg/g or urine protein-to-creatinine ratio (UPCR) ≥ 1000 mg/g) or hypertension (systolic blood pressure (SBP) ≥ 130 mmHg), from 37 clinical centers across China between November 2023 and December 2026. Data collected will include demographic and clinical characteristics, CKD etiology and staging, diagnosis and treatment patterns, clinical outcomes, healthcare resource utilization, and lifestyle factors. Patients will be followed up annually until study end, withdrawal, loss to follow-up, or death. The study will utilize both traditional chart reviews and electronic medical records for data collection, with data governance methods employed at selected centers to enhance efficiency and accuracy of patient screening and data collection. The outcomes of this registry include both disease progression and clinical outcomes. The disease progression refers to the progressive deterioration of renal function, including decline in estimated Glomerular Filtration Rate (eGFR) category and rapid progression. The clinical outcomes are renal outcomes, cardiovascular outcomes, cardio-kidney composite outcomes, and all-cause mortality. DISCUSSION: C-INSIGHT is the first nationwide initiative in China dedicated to characterizing CKD patients at high-risk for progression, focusing on the unique disease profiles, risk factors, and clinical outcomes of CKD-HP and CKD-HTN subgroups. This registry study will develop predictive models for CKD progression and clinical outcomes and identify gaps between real-world management and guideline-based care of CKD. Large-scale, detailed data on diagnosis, treatment, and outcomes may support the development of enhanced strategies for early intervention, risk stratification, and long-term management, ultimately improving clinical outcomes. This study aims to fill crucial evidence gaps in China, and the findings may provide a reference for CKD management within China or regions with similar populations. TRIAL REGISTRATION DATE: First submitted: 2023-10-31; First submitted that met QC criteria: 2023-10-31; First posted: 2023-11-07. TRIAL REGISTRATION: NCT06117852 ( ClinicalTrials.gov ).
Source: BMC Nephrology
Authors: Guihua Wang, Xueyan Bian, Qun Luo, Junwu Dong, Wenli Chen, Yan Hao, Liang Wang, Guangbiao Xu, Bin Yi, Xiaohui Liao, Chaosheng Chen, Jianying Niu, Jin Deng, Lianhua Chen, Yunfang Zhang, Tianbiao Zhou, Guisen Li, Dongliang Zhang, Yi Li, Huijuan Mao, Jicheng Lv, Qingfeng Peng, Chenli Zhang, Peng Xiang, Junfei Zhang, Hang Li, Yan Xiao, Bicheng Liu
Institutions: Zhongda Hospital Southeast University, Southeast University, Ningbo University, Ningbo University Affiliated Hospital, Ningbo No. 2 Hospital, Wuhan Puai Hospital, Central Hospital of Wuhan, Zigong First People's Hospital, Wuxi People's Hospital, Third Xiangya Hospital, Second Affiliated Hospital of Chongqing Medical University, Wenzhou Medical University, First Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of University of South China, Huaian First People’s Hospital, Second Affiliated Hospital of Shantou University Medical College, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Beijing Jishuitan Hospital, Dongguan People’s Hospital, Jiangsu Province Hospital, Peking University First Hospital, Zhuzhou Central Hospital, Second People’s Hospital of Yibin
Language: English
Subfield: Nephrology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,090
OpenAlex ID: W4415618399