echemi logo
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > Roxastat is not inferior to darbepoetin alfa in the Phase 3 trial of head-to-head treatment of anemia

    Roxastat is not inferior to darbepoetin alfa in the Phase 3 trial of head-to-head treatment of anemia

    • Last Update: 2020-06-16
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit
    Astedai recently released the results of phase III clinical trial DOLOMITES, which was conducted in adult patients with stage 3 to 5 chronic kidney disease (CKD) non-dialysis dependence (NDD) to assess the efficacy of roxadustat and darpoetbein alfa for anaemiaThe results showed that roxadustat's therapeutic effect in correcting hemoglobin levels was no worse than darbepoetin alfa (89.5% vs 78.0%; 95% CI: 5.66%, 17.36%) during the first 24 weeks of treatment, reaching the main endpoint of the study (95% CI.0)The secondary endpoint of the study was the non-disadvantage and superiority of the stratified testThe data show edigate levels of LDL cholesterol (minimum mean variance (LSM) difference of 0.403mmol/L; 95% CI: -0.510, -0.296; 0.01), the first intravenous iron (risk ratio of .45; 95% CI: 0.26, 0.78; p-0.004), roxadustat shows superiorityRoxadustat showed non-de-secrimmage in terms of average arterial pressure (LSM difference- of 0.372 mmHg; 95% CI: -1.587, 0.842) and the time at which hypertension occurred (HR-0.83; 95% CI:0.56, 1.22)In terms of safety, there was no significant difference in the overall incidence of adverse events during treatment by roxadustat and darbepoetin alfa (91.6% and 92.5%, respectively)Unconfirmed analysis of severe adverse cardiovascular events (MACE) and MACE plus in-patient unstable angina and inpatient congestive heart failure (MACE plus) showed that the two drugs had an average OF 0.81 (95% CI:0.52, 1.25) and 0.90 (95% CI: 0.61, 1.32), respectivelyRenal anemia is one of the main complications of CKD renal dysfunctionWith the progress of CKD, the prevalence and severity of CKD-related anemia increased graduallyPatients with renal anemia are difficult to correct than conventional anemia, the patients are severely weak and have poor quality of lifeCurrent standard treatments for renal anemia are erythropoietin (EPO hormone) replacement, red blood cell-generating stimulants (ESA) such as alfaibertin and intravenous iron agentsUnlike ESA, roxadustat is an oral inhibitor of hypoxic induction factor (HIF) progenitor (PH), and roxadustat can improve patient hemoglobin levels through different mechanismsAs an HIF-PH inhibitor, roxadustat activates the body's natural protection response to reduced oxygen levels in the bloodThis reaction involves the regulation of complementary processes that promote red blood cell production and increase blood oxygen carrying capacityDiscovered by FibroGen, the drug was developed in partnership with AstraZeneca in the United States, China and other markets, and with Astellas in Japan and the European Union.
    This article is an English version of an article which is originally in the Chinese language on and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to with relevant evidence.