Abstract
BackgroundRoxadustat 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/DesignThis 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.DiscussionThe 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 registrationThe 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.
Highlights
Roxadustat has been shown effective in treating patients with anemia due to chronic kidney disease
The main objective of this study is to the assess long-term association of Roxadustat on major adverse cardiovascular events (MACE), allcause 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
Summary
Roxadustat has been shown effective in treating patients with anemia due to chronic kidney disease. It is reported that more than 90% of dialysis patients have renal anemia [4], which is associated with increased risk of cardiovascular events [5, 6] and all-cause mortality [7]. Erythropoiesis-stimulating agents (ESA) are commonly used in the treatment of renal anemia It can improve hemoglobin levels, and cardiovascular outcomes in CKD patients. It can delay the progression of chronic kidney disease, reduce hospitalization, allcause mortality, and improve the quality of life of CKD patients [8]. High dose of ESA is associated with increased risk of cardiovascular events and mortality, and regardless of HGB levels [10], demonstrated by the CHOICE study. ESA resistance can occur in some patients, resulting in treatment failure
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