Abstract: TH-PO981
Low vs. Standard Starting Dose Oral Roxadustat for Treating Anemia in Chinese Patients with CKD on Dialysis: A Prospective, Randomized Clinical Trial
Session Information
- Anemia in CKD: Risk Factors, Practice Patterns, Therapies
November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Liu, Bi-Cheng, Institute of Nephrology, Zhongda Hospital, Southeast University School of Medicine, Nanjing, China
- Tu, Yan, Institute of Nephrology, Zhongda Hospital, Southeast University School of Medicine, Nanjing, China
- Xu, Yan, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
- Yao, Li, The First Hospital of China Medical University, Shenyang, Liaoning, China
- Zhang, Bei ru, Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
- Yan, Tiekun, Tianjin Medical University General Hospital, Tianjin, Tianjin, China
- Yin, Aiping, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
- Zhang, Xinzhou, Shenzhen People's Hospital, Shenzhen, Guangdong, China
- Yang, Min, The First People's Hospital of Changzhou, Changzhou, China
- Liu, Jun, Southern Medical University Nanfang Hospital, Guangzhou, Guangdong, China
- Wang, Caili, The First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou, China
- Peng, Xiaomei, The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China
- Jianqin, Wang, Lanzhou University Second Hospital, Lanzhou, Gansu, China
- Niu, Wei, FibroGen China, Beijing, Beijing, China
- Jiang, Wenqing, FibroGen China, Beijing, Beijing, China
Background
Part 1 of this phase 4 study (NCT04059913) descriptively evaluated the efficacy and safety of a one dose step lower roxadustat starting dose in Chinese chronic kidney disease patients receiving dialysis as compared to the approved standard starting dose.
Methods
ESA naïve and previously ESA-treated patients on dialysis were randomized to receive a standard or lower roxadustat starting dose TIW for 20 weeks, titrated to maintain hemoglobin (Hb) within 100–120 g/L. The primary endpoints were the proportion of ESA-naïve patients achieving Hb≥110 g/L in the first 20 weeks and the proportion of ESA-treated patients achieving mean Hb≥100 g/L averaged over week 17 - 21 visit. Other efficacy endpoints include change from baseline (CFB) in Hb over week 17-21 etc. Adverse events (AEs) were monitored and assessed.
Results
Among 318 patients randomized to the lower vs. standard starting dose (ESA-naïve: 57 vs. 56; ESA-treated: 103 vs. 102), baseline characteristics including overall Hb (ESA-naïve: 87.73 vs. 86.17 g/L; ESA-treated: 104.81 vs. 105.34 g/L) were generally comparable. Numerically comparable proportions of low and standard dose patients within the ESA naïve and ESA-treated groups achieved the pre-defined Hb target levels (ESA naïve: 77.2% vs. 73.2%; ESA-treated: 82.5% vs. 79.0%). The mean Hb CFB to the average over week 17-21 visits were also comparable (ESA-naïve:20.7 g/L vs. 21.6 g/L; ESA-treated:4.9 g/L vs. 6.0 g/L). Treatment-emergent AEs (TEAEs) were comparable between treatment arms.
Conclusion
One dose level lower roxadustat starting dose showed similar efficacy and safety profile as compared to the approved standard starting dose in Chinese CKD patients receiving dialysis.
Funding
- Commercial Support – This study was sponsored by FibroGen and AstraZeneca.