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

The DOI matches its Crossref record; 32 of the 32 references it cites were found in a registry or an index.

Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis

Open access
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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Research works printed but not linked: 3

  1. Zhu LN, Lv W, Teng J, et al. Association of residual renal function at initiation of dialysis with prognosis in maintenance dialysis patients. Chin J Nephrol 2012:757-764.
  2. Collins AJ. Anaemia management prior to dialysis: cardiovascular and cost-benefit observations. Nephrol Dial Transplant 2003;18:Suppl 2:ii2-ii6.12819293
  3. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int Suppl 2013;3(1):1-150 (https://kdigo.org/wp-content/uploads/2017/02/KDIGO_2012_CKD_GL.pdf).

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Metadata

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
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
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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