Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis
This phase 3, randomized trial in China compared the efficacy and safety of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, with placebo for anemia in patients with CKD who were not undergoing dialysis. Roxadustat was superior to placebo in increasing and maintaining hemog...
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| Published in | The New England journal of medicine Vol. 381; no. 11; pp. 1001 - 1010 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Massachusetts Medical Society
12.09.2019
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| Subjects | |
| Online Access | Get full text |
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| Abstract | This phase 3, randomized trial in China compared the efficacy and safety of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, with placebo for anemia in patients with CKD who were not undergoing dialysis. Roxadustat was superior to placebo in increasing and maintaining hemoglobin levels. |
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| AbstractList | 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.
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.
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.
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.). This phase 3, randomized trial in China compared the efficacy and safety of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, with placebo for anemia in patients with CKD who were not undergoing dialysis. Roxadustat was superior to placebo in increasing and maintaining hemoglobin levels. 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.BACKGROUNDRoxadustat (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.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.METHODSIn 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.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.RESULTSDuring 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.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.).CONCLUSIONSIn 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.). BackgroundRoxadustat (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.MethodsIn 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.ResultsDuring 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.ConclusionsIn 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.) |
| Author | Tao, Ye Xing, Changying Chen, Jianghua Liu, Bi-Cheng Hao, Chuanming Yin, Aiping Wang, Chunrong Liao, Yunhua Leong, Robert Liu, Zhengrong Luo, Laimin Zuo, Li Neff, Thomas Peng, Xiaomei Yu, Kin-Hung P Chen, Nan Hao, Li Lin, Hongli Liang, Xinling Liu, Cameron Szczech, Lynda |
| Author_xml | – sequence: 1 givenname: Nan surname: Chen fullname: Chen, Nan organization: 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 Department of Nephrology, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People’s Hospital, Beijing (L.Z.) — all in China; 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and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.) – sequence: 11 givenname: Jianghua surname: Chen fullname: Chen, Jianghua organization: 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 Department of Nephrology, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People’s Hospital, Beijing (L.Z.) — all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.) – sequence: 12 givenname: Laimin surname: Luo fullname: Luo, Laimin organization: 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 Department of Nephrology, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People’s Hospital, Beijing (L.Z.) — all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.) – sequence: 13 givenname: Li surname: Zuo fullname: Zuo, Li organization: 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 Department of Nephrology, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People’s Hospital, Beijing (L.Z.) — all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.) – sequence: 14 givenname: Yunhua surname: Liao fullname: Liao, Yunhua organization: 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 Department of Nephrology, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People’s Hospital, Beijing (L.Z.) — all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.) – sequence: 15 givenname: Bi-Cheng surname: Liu fullname: Liu, Bi-Cheng organization: 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 Department of Nephrology, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People’s Hospital, Beijing (L.Z.) — all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.) – sequence: 16 givenname: Robert surname: Leong fullname: Leong, Robert organization: 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 Department of Nephrology, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People’s Hospital, Beijing (L.Z.) — all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.) – sequence: 17 givenname: Chunrong surname: Wang fullname: Wang, Chunrong organization: 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 Department of Nephrology, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People’s Hospital, Beijing (L.Z.) — all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.) – sequence: 18 givenname: Cameron surname: Liu fullname: Liu, Cameron organization: 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 Department of Nephrology, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People’s Hospital, Beijing (L.Z.) — all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.) – sequence: 19 givenname: Thomas surname: Neff fullname: Neff, Thomas organization: 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 Department of Nephrology, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People’s Hospital, Beijing (L.Z.) — all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.) – sequence: 20 givenname: Lynda surname: Szczech fullname: Szczech, Lynda organization: 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 Department of Nephrology, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People’s Hospital, Beijing (L.Z.) — all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.) – sequence: 21 givenname: Kin-Hung P surname: Yu fullname: Yu, Kin-Hung P organization: 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 Department of Nephrology, First Affiliated Hospital of Xi’an Jiaotong University, Xi’an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People’s Hospital, Beijing (L.Z.) — all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.) |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31340089$$D View this record in MEDLINE/PubMed |
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| Snippet | This phase 3, randomized trial in China compared the efficacy and safety of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, with... Roxadustat (FG-4592) is an oral inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase that stimulates erythropoiesis and regulates iron metabolism. In... BackgroundRoxadustat (FG-4592) is an oral inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase that stimulates erythropoiesis and regulates iron... |
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| SubjectTerms | Acidosis Acidosis - chemically induced Adult Aged Anemia Anemia - drug therapy Anemia - etiology Cardiovascular disease Cholesterol Cholesterol - blood Dialysis Double-Blind Method Erythropoiesis Erythropoietin Female Glycine - adverse effects Glycine - analogs & derivatives Glycine - therapeutic use Heart failure Hematinics - adverse effects Hematinics - therapeutic use Hemodialysis Hemoglobin Hemoglobins - analysis Hepcidin Homeostasis Humans Hyperkalemia Hyperkalemia - chemically induced Hypoxia-Inducible Factor-Proline Dioxygenases - antagonists & inhibitors Hypoxia-inducible factors Iron Isoquinolines - adverse effects Isoquinolines - therapeutic use Kidney diseases Male Metabolic acidosis Metabolism Middle Aged Patients Prolyl hydroxylase Renal Insufficiency, Chronic - blood Renal Insufficiency, Chronic - complications |
| Title | Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis |
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