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Article: Roxadustat for CKD-related Anemia in Non-dialysis Patients

TitleRoxadustat for CKD-related Anemia in Non-dialysis Patients
Authors
Keywordsanemia
chronic kidney disease
rescue therapy
roxadustat
Issue Date2021
PublisherElsevier: Open Access Journals. The Journal's web site is located at http://www.journals.elsevier.com/kidney-international-reports/
Citation
Kidney International Reports, 2021, v. 6 n. 3, p. 624-635 How to Cite?
AbstractIntroduction: Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and improves iron metabolism. We assessed the efficacy and tolerability of roxadustat in patients with chronic kidney disease (CKD)-related anemia not on dialysis. Methods: ANDES was a global Phase 3 randomized study in which adults with stage 3–5 CKD not on dialysis received roxadustat or placebo. Patients were initially dosed thrice weekly; dose was titrated to achieve a hemoglobin level ≥11.0 g/dl, followed by titration for maintenance. The primary endpoints were change in hemoglobin (weeks 28–52) and proportion of patients achieving a hemoglobin response (hemoglobin ≥11.0 g/dl and increase ≥1.0 g/dl [baseline >8.0 g/dl], or increase ≥2.0 g/dl [baseline ≤8.0 g/dl]) (week 24). Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were recorded. Results: In roxadustat (n = 616) and placebo (n = 306) groups, hemoglobin mean (SD) change from baseline over weeks 28–52 was significantly larger for roxadustat (2.00 [0.95]) versus placebo (0.16 [0.90]), corresponding to least-squares mean difference of 1.85 g/dl (95% confidence interval [CI] 1.74–1.97; P < 0.0001). The proportion of patients achieving a response at week 24 was larger for roxadustat (86.0%; 95% CI 83.0%–88.7%) versus placebo (6.6%; 95% CI 4.1%–9.9%; P < 0.0001). The proportion of patients receiving rescue therapy at week 52 was smaller for roxadustat (8.9%) versus placebo (28.9%); hazard ratio, 0.19 (95% CI 0.14–0.28; P < .0001). The incidences of TEAEs and TESAEs were comparable. Conclusion: This study showed that roxadustat corrected and maintained hemoglobin and was well tolerated in patients with CKD-related anemia not on dialysis (ClinicalTrials.gov NCT01750190).
Persistent Identifierhttp://hdl.handle.net/10722/301392
ISSN
2020 Impact Factor: 4.164
2020 SCImago Journal Rankings: 1.225
PubMed Central ID

 

DC FieldValueLanguage
dc.contributor.authorCoyne, DW-
dc.contributor.authorRoger, SD-
dc.contributor.authorShin, SK-
dc.contributor.authorKim, SG-
dc.contributor.authorCadena, AA-
dc.contributor.authorMoustafa, MA-
dc.contributor.authorChan, TM-
dc.contributor.authorBesarab, A-
dc.contributor.authorChou, W-
dc.contributor.authorBradley, C-
dc.contributor.authorEyassu, M-
dc.contributor.authorLeong, R-
dc.contributor.authorLee, TT-
dc.contributor.authorSaikali, KG-
dc.contributor.authorSzczech, L-
dc.contributor.authorYu, KH-
dc.date.accessioned2021-07-27T08:10:22Z-
dc.date.available2021-07-27T08:10:22Z-
dc.date.issued2021-
dc.identifier.citationKidney International Reports, 2021, v. 6 n. 3, p. 624-635-
dc.identifier.issn2468-0249-
dc.identifier.urihttp://hdl.handle.net/10722/301392-
dc.description.abstractIntroduction: Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and improves iron metabolism. We assessed the efficacy and tolerability of roxadustat in patients with chronic kidney disease (CKD)-related anemia not on dialysis. Methods: ANDES was a global Phase 3 randomized study in which adults with stage 3–5 CKD not on dialysis received roxadustat or placebo. Patients were initially dosed thrice weekly; dose was titrated to achieve a hemoglobin level ≥11.0 g/dl, followed by titration for maintenance. The primary endpoints were change in hemoglobin (weeks 28–52) and proportion of patients achieving a hemoglobin response (hemoglobin ≥11.0 g/dl and increase ≥1.0 g/dl [baseline >8.0 g/dl], or increase ≥2.0 g/dl [baseline ≤8.0 g/dl]) (week 24). Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were recorded. Results: In roxadustat (n = 616) and placebo (n = 306) groups, hemoglobin mean (SD) change from baseline over weeks 28–52 was significantly larger for roxadustat (2.00 [0.95]) versus placebo (0.16 [0.90]), corresponding to least-squares mean difference of 1.85 g/dl (95% confidence interval [CI] 1.74–1.97; P < 0.0001). The proportion of patients achieving a response at week 24 was larger for roxadustat (86.0%; 95% CI 83.0%–88.7%) versus placebo (6.6%; 95% CI 4.1%–9.9%; P < 0.0001). The proportion of patients receiving rescue therapy at week 52 was smaller for roxadustat (8.9%) versus placebo (28.9%); hazard ratio, 0.19 (95% CI 0.14–0.28; P < .0001). The incidences of TEAEs and TESAEs were comparable. Conclusion: This study showed that roxadustat corrected and maintained hemoglobin and was well tolerated in patients with CKD-related anemia not on dialysis (ClinicalTrials.gov NCT01750190).-
dc.languageeng-
dc.publisherElsevier: Open Access Journals. The Journal's web site is located at http://www.journals.elsevier.com/kidney-international-reports/-
dc.relation.ispartofKidney International Reports-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectanemia-
dc.subjectchronic kidney disease-
dc.subjectrescue therapy-
dc.subjectroxadustat-
dc.titleRoxadustat for CKD-related Anemia in Non-dialysis Patients-
dc.typeArticle-
dc.identifier.emailChan, TM: dtmchan@hku.hk-
dc.identifier.authorityChan, TM=rp00394-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1016/j.ekir.2020.11.034-
dc.identifier.pmid33732977-
dc.identifier.pmcidPMC7938196-
dc.identifier.scopuseid_2-s2.0-85101047915-
dc.identifier.hkuros323559-
dc.identifier.volume6-
dc.identifier.issue3-
dc.identifier.spage624-
dc.identifier.epage635-
dc.publisher.placeUnited States-

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