Cited by 584Erythropoietin and Anemia TreatmentIron Metabolism and DisordersHemoglobinopathies and Related Disorders

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Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis

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Chen, Nan, Hao, Chuanming, Peng, Xiaomei, Lin, Hongli, Yin, Aiping, Hao, Li, Tao, Ye, Liang, Xinling, Liu, Zhengrong, Xing, Changying, Chen, Jianghua, Luo, Laimin, Zuo, Li, Liao, Yunhua, Liu, Bi-Cheng, Leong, Robert, Wang, Chunrong, Liu, Cameron, Neff, Thomas, Szczech, Lynda, Yu, Kin-Hung P.·2019·New England Journal of Medicine

DOI 10.1056/nejmoa1813599

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Abstract

BACKGROUND: Roxadustat (FG-4592) is an oral inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase that stimulates erythropoiesis and regulates iron metabolism. In phase 2 studies involving patients with chronic kidney disease, roxadustat increased levels of endogenous erythropoietin to within or near the physiologic range, along with increasing hemoglobin levels and improving iron homeostasis. Additional data are needed regarding the efficacy and safety of roxadustat for the treatment of anemia in patients with chronic kidney disease who are not undergoing dialysis. METHODS: In this phase 3 trial conducted at 29 sites in China, we randomly assigned 154 patients with chronic kidney disease in a 2:1 ratio to receive roxadustat or placebo three times a week for 8 weeks in a double-blind manner. All the patients had a hemoglobin level of 7.0 to 10.0 g per deciliter at baseline. The randomized phase of the trial was followed by an 18-week open-label period in which all the patients received roxadustat; parenteral iron was withheld. The primary end point was the mean change from baseline in the hemoglobin level, averaged over weeks 7 through 9. RESULTS: During the primary-analysis period, the mean (±SD) change from baseline in the hemoglobin level was an increase of 1.9±1.2 g per deciliter in the roxadustat group and a decrease of 0.4±0.8 g per deciliter in the placebo group (P<0.001). The mean reduction from baseline in the hepcidin level (associated with greater iron availability) was 56.14±63.40 ng per milliliter in the roxadustat group and 15.10±48.06 ng per milliliter in the placebo group. The reduction from baseline in the total cholesterol level was 40.6 mg per deciliter in the roxadustat group and 7.7 mg per deciliter in the placebo group. Hyperkalemia and metabolic acidosis occurred more frequently in the roxadustat group than in the placebo group. The efficacy of roxadustat in hemoglobin correction and maintenance was maintained during the 18-week open-label period. CONCLUSIONS: In Chinese patients with chronic kidney disease who were not undergoing dialysis, those in the roxadustat group had a higher mean hemoglobin level than those in the placebo group after 8 weeks. During the 18-week open-label phase of the trial, roxadustat was associated with continued efficacy. (Funded by FibroGen and FibroGen [China] Medical Technology Development; ClinicalTrials.gov number, NCT02652819.).

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Authors: Chen, N., Hao, C., Peng, X., Lin, H., Yin, A., Hao, L., Tao, Y., Liang, X., Liu, Z., Xing, C., Chen, J., Luo, L., Zuo, L., Liao, Y., Liu, B.-C., Leong, R., Wang, C., Liu, C., Neff, T., Szczech, L., & Yu, K.-H. P.
Affiliations: Shanghai Jiao Tong University (CN)
From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People’s Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the...
ORCID: Chen, Nan
Lin, Hongli
Tao, Ye
Liang, Xinling
Liu, Zhengrong
Chen, Jianghua
Luo, Laimin
Zuo, Li
Liao, Yunhua
Liu, Bi-Cheng
Wang, Chunrong
Yu, Kin-Hung P.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2019-09-12
Volume: 381
Issue: 11
Pages: 1001-1010
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1813599
OpenAlex: W2963534431
Cited by: 582
References: 32
Citations by year: 2026: 53 · 2025: 62 · 2024: 68 · 2023: 68 · 2022: 96 · 2021: 112 · 2020: 100 · 2019: 22
FWCI: 58.49
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Funders: FibroGen
Topics: Health Sciences › Medicine › Hematology › Erythropoietin and Anemia Treatment
Health Sciences › Medicine › Hematology › Iron Metabolism and Disorders
Health Sciences › Medicine › Genetics (clinical) › Hemoglobinopathies and Related Disorders
Keywords: roxadustat, chronic kidney disease, anemia of chronic kidney disease, HIF prolyl hydroxylase inhibitors, non-dialysis patients, hemoglobin increase, hepcidin, iron metabolism, erythropoiesis, hyperkalemia, metabolic acidosis, total cholesterol, Chinese patients, open-label extension
MeSH terms: Acidosis, Adult, Aged, Anemia, Cholesterol, Double-Blind Method, Female, Glycine, Hematinics, Hemoglobins, Humans, Hyperkalemia, Isoquinolines, Male, Middle Aged, Renal Insufficiency, Chronic, Hypoxia-Inducible Factor-Proline Dioxygenases

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Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis

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