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      Hypoxia-Inducible Factor-Proline Hydroxylase Inhibitor in the Treatment of Renal Anemia

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          Abstract

          Background: Anemia is a common complication in CKD patients. Despite the use of iron and erythropoietin-stimulating agents, the control rate of anemia in CKD is not satisfying. Novel drugs are needed for anemia correction. Summary: HIF-PHI, hypoxia-inducible factor-proline hydroxylase inhibitor, a novel class of therapeutic agents, has been developed to treat anemia in CKD patients. Its main effects comprised boosting EPO production, enhancing iron utilization, and suppressing hepcidin production. Several stage 2 and stage 3 clinical trials have been run to test its efficacy and safety in both nondialysis and dialysis patients, of which the results are very encouraging. Here, we summarize the mechanism, clinical applications, and clinical trials of HIF-PHI in treating renal anemia in order to give an overview of the new drug in clinical practices. Key Messages: HIF-PHI is a novel therapeutic agent of treating renal anemia in CKD patients. It is quite effective in improving anemia, which is unaffected by inflammation. Besides, it may ameliorate lipid metabolism as well. Furthermore, the oral form may improve patients’ compliances with treatment. Thus, it may be a good alternative of anemia correction in CKD patients.

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          Correction of anemia with epoetin alfa in chronic kidney disease.

          Ajay K. Singh, Lynda Szczech, Kezhen L. Tang … (2006)
          Anemia, a common complication of chronic kidney disease, usually develops as a consequence of erythropoietin deficiency. Recombinant human erythropoietin (epoetin alfa) is indicated for the correction of anemia associated with this condition. However, the optimal level of hemoglobin correction is not defined. In this open-label trial, we studied 1432 patients with chronic kidney disease, 715 of whom were randomly assigned to receive a dose of epoetin alfa targeted to achieve a hemoglobin level of 13.5 g per deciliter and 717 of whom were assigned to receive a dose targeted to achieve a level of 11.3 g per deciliter. The median study duration was 16 months. The primary end point was a composite of death, myocardial infarction, hospitalization for congestive heart failure (without renal replacement therapy), and stroke. A total of 222 composite events occurred: 125 events in the high-hemoglobin group, as compared with 97 events in the low-hemoglobin group (hazard ratio, 1.34; 95% confidence interval, 1.03 to 1.74; P=0.03). There were 65 deaths (29.3%), 101 hospitalizations for congestive heart failure (45.5%), 25 myocardial infarctions (11.3%), and 23 strokes (10.4%). Seven patients (3.2%) were hospitalized for congestive heart failure and myocardial infarction combined, and one patient (0.5%) died after having a stroke. Improvements in the quality of life were similar in the two groups. More patients in the high-hemoglobin group had at least one serious adverse event. The use of a target hemoglobin level of 13.5 g per deciliter (as compared with 11.3 g per deciliter) was associated with increased risk and no incremental improvement in the quality of life. (ClinicalTrials.gov number, NCT00211120 [ClinicalTrials.gov].). Copyright 2006 Massachusetts Medical Society.
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            A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease.

            Marc Pfeffer, Emmanuel A. Burdmann, Chao-Yin Chen … (2009)
            Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. Although darbepoetin alfa can effectively increase hemoglobin levels, its effect on clinical outcomes in these patients has not been adequately tested. In this study involving 4038 patients with diabetes, chronic kidney disease, and anemia, we randomly assigned 2012 patients to darbepoetin alfa to achieve a hemoglobin level of approximately 13 g per deciliter and 2026 patients to placebo, with rescue darbepoetin alfa when the hemoglobin level was less than 9.0 g per deciliter. The primary end points were the composite outcomes of death or a cardiovascular event (nonfatal myocardial infarction, congestive heart failure, stroke, or hospitalization for myocardial ischemia) and of death or end-stage renal disease. Death or a cardiovascular event occurred in 632 patients assigned to darbepoetin alfa and 602 patients assigned to placebo (hazard ratio for darbepoetin alfa vs. placebo, 1.05; 95% confidence interval [CI], 0.94 to 1.17; P=0.41). Death or end-stage renal disease occurred in 652 patients assigned to darbepoetin alfa and 618 patients assigned to placebo (hazard ratio, 1.06; 95% CI, 0.95 to 1.19; P=0.29). Fatal or nonfatal stroke occurred in 101 patients assigned to darbepoetin alfa and 53 patients assigned to placebo (hazard ratio, 1.92; 95% CI, 1.38 to 2.68; P<0.001). Red-cell transfusions were administered to 297 patients assigned to darbepoetin alfa and 496 patients assigned to placebo (P<0.001). There was only a modest improvement in patient-reported fatigue in the darbepoetin alfa group as compared with the placebo group. The use of darbepoetin alfa in patients with diabetes, chronic kidney disease, and moderate anemia who were not undergoing dialysis did not reduce the risk of either of the two primary composite outcomes (either death or a cardiovascular event or death or a renal event) and was associated with an increased risk of stroke. For many persons involved in clinical decision making, this risk will outweigh the potential benefits. (ClinicalTrials.gov number, NCT00093015.) 2009 Massachusetts Medical Society
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              Roxadustat Treatment for Anemia in Patients Undergoing Long-Term Dialysis

              Nan Chen, Chuanming Hao, Bi-Cheng Liu … (2019)
              Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and regulates iron metabolism. Additional data are needed regarding the effectiveness and safety of roxadustat as compared with standard therapy (epoetin alfa) for the treatment of anemia in patients undergoing dialysis.
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                Author and article information

                Journal
                Journal ID (publisher-id): KDD
                Journal ID (pmc): KDD
                Journal ID (doi): 10.1159/issn.2296-9357
                Title: Kidney Diseases
                Publisher: S. Karger AG
                ISSN (Print): 2296-9381
                ISSN (Electronic): 2296-9357
                Publication date Subscription-year: 2021
                Publication date (Print): January 2021
                Publication date (Electronic): 17 December 2020
                Volume: 7
                Issue: 1
                Pages: 1-9
                Affiliations
                Department of Nephrology, Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
                Author notes
                *Nan Chen, Department of Nephrology, Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197 Ruijin Er Rd., Shanghai 200025 (China), cnrj100@126.com
                Article
                Publisher ID: 510587 Other ID: Kidney Dis 2021;7:1–9
                DOI: 10.1159/000510587
                SO-VID: 21c2c283-44d6-47e7-96f4-1e26aafaacb0
                Copyright © © 2020 The Author(s) Published by S. Karger AG, Basel
                License:

                This article is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND). Usage and distribution for commercial purposes as well as any distribution of modified material requires written permission. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                History
                Date received : 03 April 2020
                Date accepted : 26 July 2020
                Page count
                Tables: 4, Pages: 9
                Categories
                Subject: Review Article

                ScienceOpen disciplines: Cardiovascular Medicine,Nephrology
                Keywords: Hypoxia-inducible factor-proline hydroxylase inhibitor,Chronic kidney disease,Anemia
                Data availability:
                ScienceOpen disciplines: Cardiovascular Medicine, Nephrology
                Keywords: Hypoxia-inducible factor-proline hydroxylase inhibitor, Chronic kidney disease, Anemia

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