Kidney Week

Abstract: TH-PO1153

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Subjects with CKD Not on Dialysis

Session Information

• Late-Breaking Clinical Trials Posters
  October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Anemia and Iron Metabolism

• No subcategory defined

Authors

• Chen, Nan, Institute of Nephrology, Department of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

Nan Chen,

• Hao, Chuan-Ming, Division of Nephrology, Huashan Hospital Fudan University, Shanghai, China

Chuan-Ming Hao,

• Peng, Xiaomei, Department of Nephrology, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China

Xiaomei Peng,

• Lin, Hong Li, Department of Nephrology, The First Affiliated Hospital of Dalian Medical University, Dalian, China

Hong Li Lin,

• Yin, Aiping, Dialysis Center, The First Affiliated Hospital of Xi'an Jiaotong University, Xian, China

Aiping Yin,

• Hao, Li, Anhui Medical University Affiliated Second Hospital, Hefei, China

Li Hao,

• Tao, Ye, Division of Nephrology, West China Hospital, Chengdu, China

Ye Tao,

• Liang, Xinling, Division of Nephrology, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China

Xinling Liang,

• Liu, Zhengrong, Renal Division, Nanfang Hospital, Southern Medical University, The National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Guangzhou, China

Zhengrong Liu,

• Xing, Chang Ying, Department of Nephrology, The First Affiliated Hospital（Jiangsu Province Hospital), Nanjing Medical University, Nanjing, China

Chang Ying Xing,

• Chen, Jianghua, Zhejiang University Affiliated First Hospital, Hangzhou, China

Jianghua Chen,

• Luo, Laimin, The First Affiliated Hospital of Nanchang University, Nanchang, China

Laimin Luo,

• Zuo, Li, Department of Nephrology, Peking University People's Hospital, Beijing, China

Li Zuo,

• Liao, Yunhua, Department of Nephrology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China

Yunhua Liao,

• Liu, Bi-Cheng, Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine, Nanjing, China

Bi-Cheng Liu,

• Leong, Robert, FibroGen Inc., San Francisco, California, United States

Robert Leong,

• Wang, Chunrong, FibroGen, Shanghai, China

Chunrong Wang,

• Liu, Cameron S., FibroGen Inc., San Francisco, California, United States

Cameron S. Liu,

• Neff, Thomas B., FibroGen Inc., San Francisco, California, United States

Thomas B. Neff,

• Szczech, Lynda, FibroGen Inc., San Francisco, California, United States

Lynda Szczech,

• Yu, Kin-Hung Peony, FibroGen Inc., San Francisco, California, United States

Kin-Hung Peony Yu,

Background

Roxadustat (FG-4592) is an oral hypoxia–inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and regulates iron metabolism.

Methods

In this phase 3 trial, Chinese patients with hemoglobin (Hb) between 7.0-10.0 g/dL and CKD not requiring dialysis were randomized and treated in a double-blind manner to roxadustat thrice-weekly or placebo (2:1) for 8-weeks; parenteral iron was withheld except for rescue. The primary endpoint was the average change in Hb from baseline to week 7-9. Following, all patients were offered open-label roxadustat for 18-weeks.

Results

The safety population included 152 patients (101=roxadustat, 51=placebo) in the initial 8-weeks, during which subjects in the roxadustat arm had a greater mean (+SD) change from baseline in hemoglobin of 1.90 g/dL (+1.175)(mean baseline Hb 8.87 +0.81 g/dL), as compared to placebo -0.39 g/dL (+0.786)(mean baseline 8.93 +0.73 g/dL) (p<0.000000000000001). At week 9, patients randomized to roxadustat had a greater mean reduction in hepcidin at -56.14 (+63.40)(p<0.00001) vs. -15.10 (+48.06) ng/ml (p=0.172) in the placebo group (p<0.00001 between groups). At week 9, the decline from baseline was greater for lipid fractions (total cholesterol and LDL cholesterol) in the roxadustat arm (p<0.00001). The most frequent treatment-emergent adverse events were typical for this population and without trend in individual or composite events. Ninety-eight subjects completed the 18-week open-label period. Roxadustat performed similarly in the open-label as in the initial treatment period with respect to correction and maintenance of hemoglobin.

Conclusion

Roxadustat was well tolerated in patients with CKD not requiring dialysis in China and superior to placebo in correcting anemia and maintaining Hb levels.

Funding

• Commercial Support –