"Roxadustat"

Roxadustat for treating symptomatic anaemia in chronic kidney disease Roxadustat for treating symptomatic anaemia in chronic kidney disease Technology appraisal guidance Published: 13 July 2022 www.nice.org.uk/guidance/ta807 © NICE 2022. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of-rights).Your responsibility Your responsibility impact of implementing NICE recommendations wherever possible. Roxadustat for treating symptomatic anaemia in chronic kidney disease (TA807)© NICE 2022. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of-rights).Page 2 of26Contents Contents 1 Recommendations

Roxadustat (anaemia) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Roxadustat (renale Anämie) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 December 2021). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. A21-117 Roxadustat (renal anaemia) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A21-117 Version 1.0 Roxadustat (renal anaemia) 13 December 2021 Institute for Quality and Efficiency in Health Care

Roxadustat (Evrenzo) - treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD). Published 08 August 2022 1 SMC2461 roxadustat 20mg, 50mg, 70mg, 100mg and 150mg film-coated tablets (Evrenzo®) Astellas Pharma Ltd 08 July 2022 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission roxadustat (Evrenzo®) is accepted for restricted use within NHSScotland. Indication under review: treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD). SMC restriction: for use in patients who are non-dialysis dependent (NDD

Anemia in Chronic Kidney Disease: An assessment of roxadustat Anemia in Chronic Kidney Disease - ICER Toggle Navigation * ICER Analytics™ * Donatesearch Search: * Who We Are * History & Impact * People * Independent Funding * Careers * Frequently Asked Questions (FAQs) * Our Approach * Methods & Process * Policies * Engage with ICER * Patients * Clinicians * Manufacturers * Prospective Employees * Committees & Boards * News & Insights * Press Releases * Commentaries * Journal Articles * Weekly View * Explore Our Research * Assessments * Policy Papers * ICER Calendar * ICER ANALYTICS™ Explore Our Research / Assessments / Anemia in Chronic Kidney Disease Anemia in Chronic Kidney DiseaseAn assessment of roxadustat. Public

GVS advice roxadustat (Evrenzo) for the treatment of symptomatic anaemia in chronic kidney damage GVS advice roxadustat (Evrenzo®) for the treatment of symptomatic anaemia in chronic kidney damage | Report | National Health Care Institute Go to content You are here: Home Publications GVS advice roxadustat (Evrenzo®) for the treatment of symptomatic anaemia in chronic kidney damage Search within English part of National Health Care Institute Search GVS advice roxadustat (Evrenzo®) for the treatment of symptomatic anaemia in chronic kidney damageThe National Health Care Institute has completed its assessment (using the CBG-ZIN parallel procedure) whether roxadustat (Evrenzo®) can be included in the Medication Reimbursement System (GVS). Roxadustat is registered for the treatment of symptomatic

Roxadustat effectiveness versus ESAs in peritoneal dialysis patients during the COVID-19 pandemic: A retrospective study. The COVID-19 pandemic has made treating renal anemia in chronic kidney disease (CKD) patients undergoing peritoneal dialysis (PD) difficult. The current study aims to compare roxadustat with erythropoiesis-stimulating agents (ESAs) during the COVID-19 pandemic. We conducted a single-center, retrospective study during the COVID-19 outbreak in China, from December 7, 2022, to January 31, 2023. The study involved patients undergoing PD who were divided based on the medication used to treat renal anemia; the roxadustat group (n = 34) and the ESAs group (n = 120). We analyzed the effectiveness of treating anemia, cost, medication adherence, and clinical outcomes related to COVID

Effect of roxadustat on lowering blood lipids in peritoneal dialysis patients with anemia. To observe the effect of roxadustat on lowering blood lipids in peritoneal dialysis (PD) patients beyond treating anemia. In a prospective, multicenter clinical study, we randomly assigned (in a 1:1 ratio) 100 PD patients who had received erythropoiesis-stimulating agent therapy for at least 4 weeks to receive either roxadustat or erythropoietin (EPO) for 48 weeks. The blood lipids, hemoglobin, blood pressure, blood glucose, iron metabolism and inflammatory factors were compared between the two groups at 0, 2, 4, 8, 12, 16, 20, 24 and 48 weeks, respectively. At start of switching to roxadustat, hemoglobin seemed to rise a little faster (102.8 ± 15.4 vs. 97.1 ± 17.3 g/L at 2 weeks, > 0.05

Roxadustat Increases Markers of Calcification in Patients with End-Stage Kidney Disease: Prospective Cohort Study. To determine the effects of roxadustat on calcification when treating renal anemia in end-stage kidney disease (ESKD) patients. A prospective cohort study enrolled participants with ESKD that either received roxadustat or no roxadustat treatment. The primary outcome was the change in the degree of hydroxyapatite (HAP) crystals deposition. The secondary outcome was calcification propensity, a measure of calcification, allowing an evaluation of the conversion process from primary to secondary calciprotein particles. A total of 205 patients were enrolled, and 187 (91.2%) completed follow-up for inclusion in the analysis and were divided into the roxadustat group (n = 92) and the control

Roxadustat improves diabetic myocardial injury by upregulating HIF-1α/UCP2 against oxidative stress. Diabetes mellitus (DM), characterized by hyperglycemia, is intricately linked with cardiovascular complications. Hyperglycemia induces oxidative stress, compromising mitochondria energy metabolism disturbances, leading to cardiomyocyte hypoxia and dysregulation of hypoxia-inducible factor-1α (HIF -1α), thereby exacerbating diabetic myocardial injury. Roxadustat (FG-4592), as an inhibitor of HIF-PHD, reduces HIF-1α degradation and regulates the transcription and function of downstream target genes. This study explores the protective effect of FG-4592 on the diabetic myocardium and further investigates the specific mechanisms responsible for this action. We established diabetic myocardial

Comparative analysis of roxadustat efficacy between maintenance hemodialysis and peritoneal dialysis patients. This study evaluated the comparative efficacy of roxadustat for renal anemia between patients on maintenance hemodialysis (HD) and peritoneal dialysis (PD). 93 maintenance dialysis patients who regularly followed up from August 2015 to June 2021 were enrolled. Despite receiving a therapeutic dose ≥ 12,000 U/week of erythropoiesis-stimulating agents (E+SA) in the past 12 weeks, this had not worked very well. Subjects were assigned to the HD group (n = 60) or the PD group (n = 33) based on their dialysis treatment modality. All patients received oral roxadustat and were followed up for 24 weeks, after which their hemoglobin, serum iron, transferrin saturation, and ferritin were tested

Roxadustat and Oral Iron Absorption in Chinese Patients with Anemia of Chronic Kidney Disease: A Randomized, Open-Label, Phase 4 Study (ALTAI). Anemia of chronic kidney disease (CKD) has a high incidence and is associated with many disease conditions. Iron dysmetabolism is an important contributor to anemia in CKD patients. ALTAI, a randomized, active-controlled, phase 4 trial, investigated the efficacy of roxadustat versus recombinant human erythropoietin (rHuEPO) on gastrointestinal iron absorption in patients with anemia of CKD (stage 4/5). The primary endpoint was change from baseline to day 15 in gastrointestinal iron absorption (serum iron area under the concentration-time curve; AUC) following single-dose oral iron. Twenty-five patients with a mean age of 55.1 years were randomized 1:1

Roxadustat reduces left ventricular mass index compared to rHuEPO in haemodialysis patients in a randomized controlled trial. Left ventricular hypertrophy (LVH) is highly prevalent in haemodialysis (HD) patients and is associated with an increased risk of death. Roxadustat and recombinant human erythropoietin (rHuEPO, abbreviated as EPO) are the main treatment strategies for renal anaemia in HD patients, but it has not been clear whether there is a difference in their effect on LVH. In this multi-centre, prospective, randomized trial of 12-month duration, study participants were randomized in a 1:1 ratio to the roxadustat group or the EPO group. The doses of both treatment regimens were adjusted so that the patients had a haemoglobin level of 10.0-12.0 g per dL. The primary study endpoint

Impact of C-reactive protein on the effect of Roxadustat for the treatment of anemia in chronic kidney disease: a systematic review of randomized controlled trials. Chronic inflammation, reflected by an increased blood C-reactive protein (CRP) level, is common in patients with chronic kidney disease (CKD) and is involved in the development of renal anemia. This systematic review aims . Additionally, further analysis was conducted in the CRP ≥ ULN group comparing HIF-PHIs and erythropoiesis-stimulating agents (ESA). A total of 7 studies from 6 publications were included in the analysis. In the comparison between the CRP ≥ ULN group and the CRP < ULN group, 524 patients from 4 studies were incorporated into the analysis. All patients received roxadustat as the primary intervention

Activation of the hypoxia-inducible factor pathway by roxadustat improves glucose metabolism in human primary myotubes from men. Hypoxia-inducible factor prolyl 4-hydroxylase (HIF-P4H) enzymes regulate adaptive cellular responses to low oxygen concentrations. Inhibition of HIF-P4Hs leads to stabilisation of hypoxia-inducible factors (HIFs) and activation of the HIF pathway affecting multiple biological processes to rescue cells from hypoxia. As evidence from animal models suggests that HIF-P4H inhibitors could be used to treat metabolic disorders associated with insulin resistance, we examined whether roxadustat, an HIF-P4H inhibitor approved for the treatment of renal anaemia, would have an effect on glucose metabolism in primary human myotubes. Primary skeletal muscle cell cultures

Roxadustat versus placebo for patients with lower-risk myelodysplastic syndrome: MATTERHORN phase 3, double-blind, randomized controlled trial. In patients with lower-risk myelodysplastic syndromes/neoplasms (MDS), response to first-line therapy is limited and transient. The MATTERHORN randomized, double-blind, phase 3 trial evaluated roxadustat versus placebo for patients with transfusion -dependent, lower-risk MDS. Eligible patients had very low-, low-, or intermediate-risk MDS with or without prior erythropoiesis-stimulating agent treatment, and a transfusion burden of 1-4 packed red blood cell (pRBC) units every 8 weeks (Q8W). Patients were randomized (3:2) to oral roxadustat (2.5 mg/kg) or placebo, both three times weekly, with best supportive care. Primary efficacy endpoint

Efficacy and Safety of Roxadustat for Anemia in Patients Receiving Chemotherapy for Nonmyeloid Malignancies: A Randomized, Open-Label, Active-Controlled Phase III Study. We evaluated the efficacy and safety of roxadustat, a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor, for chemotherapy-induced anemia (CIA) in patients with nonmyeloid malignancies receiving multicycle treatments of chemotherapy. In this open-label, noninferiority phase III study conducted at 44 sites in China, 159 participants age ≥18 years with CIA nonmyeloid malignancy and CIA were randomly assigned (1:1) to oral roxadustat or subcutaneous recombinant human erythropoietin-α (rHuEPO-α) three times a week for 12 weeks. Roxadustat starting dosages were 100, 120, and 150 mg three times a week

Roxadustat Versus Epoetin Alfa for Treating Anemia in Patients with Chronic Kidney Disease on Dialysis: Results from the Randomized Phase 3 ROCKIES Study Concerns regarding cardiovascular safety with current treatments for anemia in patients with dialysis-dependent (DD)-CKD have encouraged the development of alternatives. Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor , stimulates erythropoiesis by increasing endogenous erythropoietin and iron availability. In this open-label phase 3 study, patients with DD-CKD and anemia were randomized 1:1 to oral roxadustat three times weekly or parenteral epoetin alfa per local clinic practice. Initial roxadustat dose depended on erythropoiesis-stimulating agent dose at screening for patients already on them and was weight-based

Open-label, Phase 2 study of roxadustat for the treatment of anemia in patients receiving chemotherapy for non-myeloid malignancies. Anemia is a common side effect of myelosuppressive chemotherapy; however, chemotherapy-induced anemia (CIA) management options are suboptimal. We evaluated the efficacy and safety of roxadustat in this setting. This open-label Phase 2 study included patients with non-myeloid malignancies and CIA (hemoglobin [Hb] ≤10 g/dL) who had planned concurrent myelosuppressive chemotherapy for ≥8 additional weeks. Oral roxadustat was administered for ≤16 weeks (starting dose 2.0 or 2.5 mg/kg, then titrated every 4 weeks). The primary efficacy endpoint was mean maximum change in Hb within 16 weeks of baseline without red blood cell (RBC) transfusion. Patients were

Safety of Roxadustat Versus Erythropoiesis-Stimulating Agents in Patients with Anemia of Non-dialysis-Dependent or Incident-to-Dialysis Chronic Kidney Disease: Pooled Analysis of Four Phase 3 Studies. This study was conducted to elucidate the safety of roxadustat, an oral medication, in patients with non-dialysis-dependent (NDD) or incident dialysis dialysis-dependent (ID-DD) chronic kidney disease (CKD). Safety results from four phase 3, randomized, open-label studies comparing roxadustat to an erythropoiesis-stimulating agent (ESA) in men and women with NDD or ID-DD CKD with anemia were pooled and evaluated. Endpoints were time to major adverse cardiovascular event (MACE; myocardial infarction, stroke, and all-cause mortality) and MACE+ (MACE plus congestive heart failure or unstable

Retracted: Efficacy and Mechanism of Roxadustat plus Oral Iron in the Treatment of Elderly Chronic Kidney Disease with Anemia. [This retracts the article DOI: 10.1155/2022/9192655.].