Roxadustat in treating anemia in dialysis patients (ROAD): protocol and rationale of a multicenter prospective observational cohort study

• Published in: BMC nephrology Vol. 22; no. 1; pp. 28 - 5
• Main Authors: Zhang, Yaling, Ren, Song, Xue, Hen, Wang, Amanda Y, Zou, Yang, Cai, Yanrong, He, Jingdong, Yuan, Xiaoling, Jiang, Feifei, Wei, Jinxi, Yang, Dongmei, He, Dong, Hu, Shide, Lei, Min, Deng, Fei, Chen, Jin, Wang, Xia, He, Qiang, Li, Guisen, Hong, Daqing
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 13.01.2021; BioMed Central; BMC
• Subjects: Anemia; Anemia - drug therapy; Anemia - etiology; Angina pectoris; Blood diseases; Blood transfusions; Cerebral infarction; Clinical Protocols; Clinical trials; Cohort analysis; Cohort Studies; Congestive heart failure; Consent; Costs; Data entry; Dialysis; Drug dosages; Drug therapy; Glycine - analogs & derivatives; Glycine - therapeutic use; Hemodialysis; Hemodialysis patients; Hemoglobin; Hospitalization; Hospitals; Humans; Hypoxia; Iron; Isoquinolines - therapeutic use; Kidney diseases; Medical records; Metabolism; Mortality; Multicenter Studies as Topic; Myocardial infarction; Nephrology; Observational studies; Observational Studies as Topic; Patients; Peritoneal dialysis; Prospective Studies; Quality control; Quality of life; Questionnaires; Renal Dialysis; Renal Insufficiency, Chronic - complications; Renal Insufficiency, Chronic - therapy; Research Design; Roxadustat renal anemia hemodialysis; Software; Study Protocol; China; Roxadustat renal anemia hemodialysis
• ISSN: 1471-2369; 1471-2369
• DOI: 10.1186/s12882-021-02229-w

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. 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. 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. 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 .