Yaling Zhang1, Song Ren1, Hen Xue2, Amanda Y Wang3,4,5, Yang Zou1, Yanrong Cai6, Jingdong He7, Xiaoling Yuan8, Feifei Jiang9, Jinxi Wei10, Dongmei Yang11, Dong He12, Shide Hu13, Min Lei14, Fei Deng1, Jin Chen1, Xia Wang15, Qiang He16, Guisen Li17, Daqing Hong18. 1. Renal Department and Nephrology Institute, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, No. 32, West 2nd Duan, 1st Circle Road, Qingyang District, Chengdu, Sichuan, China. 2. Department of Nephrology, Ya'an People's Hospital, 625000, Ya'an, Sichuan, China. 3. The Renal and Metabolic Division, The George Institute for Global Health, University of New South Wales, Sydney, 2042, Australia. 13111865150@163.com. 4. Concord Clinical School, The University of Sydney, Sydney, 2042, Australia. 13111865150@163.com. 5. Department of Renal Medicine, Concord Repatriation General Hospital, Beijing Friendship Hospital, Beijing, China. 13111865150@163.com. 6. Department of Nephrology, 610000, Gao Xin Boli Hospital,Chengdu, China. 7. Department of Nephrology, The Second Affiliated Hospital of Chengdu Medical College, National Nuclear Corporation 416 Hospital, 610000, Chengdu, China. 8. Department of Nephrology, Sichuan Science City Hospital, 621000, Mianyang, China. 9. Department of Nephrology, Chengdu Jinniu District People's Hospital, 610036, Chengdu, China. 10. Hemodialysis center,Pidu District People's Hospital, 611730, Chengdu, China. 11. Department of Nephrology, Mianyang Anzhou People's Hospital, 621000, Mianyang, China. 12. Department of Nephrology, The People's Hospital of Mianyang, 621000, Mianyang, China. 13. Department of Nephrology, Sichuan Mianyang 404 Hospital, 621000, Mianyang, China. 14. Department of Nephrology, Affiliated Hospital of Chengdu University, 610081, Chengdu, China. 15. The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia. 16. Renal Department and Nephrology Institute, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, No. 32, West 2nd Duan, 1st Circle Road, Qingyang District, Chengdu, Sichuan, China. 13111865150@163.com. 17. Renal Department and Nephrology Institute, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, No. 32, West 2nd Duan, 1st Circle Road, Qingyang District, Chengdu, Sichuan, China. guisenli@163.com. 18. Renal Department and Nephrology Institute, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, No. 32, West 2nd Duan, 1st Circle Road, Qingyang District, Chengdu, Sichuan, China. hongdaqing11@126.com.
Abstract
BACKGROUND: Roxadustat has been shown effective in treating patients with anemia due to chronic kidney disease. However, its long-term effect on clinical outcomes and socioeconomic burden and safety remains unclear. METHODS/ DESIGN: This is a multicenter, prospective, longitudinal observational cohort study assessing if Roxadustat improves prognosis in dialysis patients. Primary outcomes will be major adverse cardiovascular events (MACE), defined as composites of cardiovascular death, myocardial infarction, cerebral infarction, hospitalization because of heart failure; all-cause mortality, and annual economic costs in two years. The data will be collected via Research electronic data capture (REDCap) based database as well as software-based dialysis registry of Sichuan province. The primary outcomes for the ROAD study participants will be compared with those in the dialysis registry cohort. Data at baseline and study follow up will also be compared to assess the association between Roxadustat and long-term clinical outcomes. DISCUSSION: The main objective of this study is to the assess long-term association of Roxadustat on MACE, all-cause mortality, socio-economic burden, safety in dialysis patients, which will provide guidance for designing further large randomized controlled trials to investigate this clinic question. STUDY REGISTRATION: The study has been registered in Chinese Clinical Trials Registry (ROAD, ROxadustat in treating Anemia in Dialysis patients, registration number ChiCTR1900025765) and provincial observational cohort database (Renal disEAse observational CoHort database, REACH, ChiCTR1900024926), registered 07 September 2019, http://www.chictr.org.cn .
BACKGROUND: Roxadustat has been shown effective in treating patients with anemia due to chronic kidney disease. However, its long-term effect on clinical outcomes and socioeconomic burden and safety remains unclear. METHODS/ DESIGN: This is a multicenter, prospective, longitudinal observational cohort study assessing if Roxadustat improves prognosis in dialysis patients. Primary outcomes will be major adverse cardiovascular events (MACE), defined as composites of cardiovascular death, myocardial infarction, cerebral infarction, hospitalization because of heart failure; all-cause mortality, and annual economic costs in two years. The data will be collected via Research electronic data capture (REDCap) based database as well as software-based dialysis registry of Sichuan province. The primary outcomes for the ROAD study participants will be compared with those in the dialysis registry cohort. Data at baseline and study follow up will also be compared to assess the association between Roxadustat and long-term clinical outcomes. DISCUSSION: The main objective of this study is to the assess long-term association of Roxadustat on MACE, all-cause mortality, socio-economic burden, safety in dialysis patients, which will provide guidance for designing further large randomized controlled trials to investigate this clinic question. STUDY REGISTRATION: The study has been registered in Chinese Clinical Trials Registry (ROAD, ROxadustat in treating Anemia in Dialysis patients, registration number ChiCTR1900025765) and provincial observational cohort database (Renal disEAse observational CoHort database, REACH, ChiCTR1900024926), registered 07 September 2019, http://www.chictr.org.cn .
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