MO536CHINESE CHRONIC RENAL INSUFFICIENCY STUDY: BASED ON SMARTPHONE PLATFORM (C- CRISS): DESIGN AND METHOD

Abstract

Abstract Background and Aims Abnormal mineral bone metabolism of chronic kidney disease (CKD-MBD) is the most common CKD complication. However, fewer data concerning the relationship between bone metabolic indexes, such as high serum phosphorus and cardiovascular diseases, bone mass reduction, and fracture, is available in Chinese adult patients. The Chinese Chronic Renal Insufficiency Study: Based on Smartphone Platform (C-CRISS) is established to explore the relationship between bone metabolic markers and other non-traditional risk factors with renal function progression, cardiovascular (CVD), and cerebrovascular diseases (BVD), and bone loss in CKD patients. Method/design The C-CRISS study is a multi-center prospective cohort study in China. It will recruit 3360 pre-dialysis patients aged 18 to 74 years and follow up for at least two years. The individuals with CKD G3b-5ND will account for over 70 percent of the study population. Active glomerulonephritis, rapidly progressing and advanced heart, liver, and tumor diseases will be excluded. The primary composite endpoints include the events of progression to ESRD, cardiovascular events, and death. The participants will undergo the clinical evaluation at baseline and clinic visits at six-monthly intervals in traditional consultation ways. The CVD, BVD, retinopathy, DXR, and other complications will be measured annually. Data on the questionnaire, diet, quality of life, and patients’ status during follow-up will be collected by the smartphone platform developed for this study. The sample size will enable us to have 80% power to detect a 2.0 risk ratio of CVD events in CKD G4 patients compared with CKD G3a patients. Conclusion The C-CRISS study would provide evidence of the potential risk of bone metabolic markers for progressive CKD and CVD/BVD. The study will also provide a new management and complication monitoring model through smartphone communication in chronic kidney disease patients. Trial registration ClinicalTrials.gov Identifier: NCT04229485