C-INSIGHT: design and methodology of a nationwide registry for high-risk chronic kidney disease in China - a study protocol.

backgroundChronic 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.

methodsThe 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 registrationNCT06117852 ( ClinicalTrials.gov ).