Abstract: TH-PO980
A National, Multi-Center, Prospective Study Evaluating the Long-Term Safety and Effectiveness of Roxadustat for Anemia Treatment in Patients with CKD (ROXSTAR Registry)
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
- Du, Xiaoying, Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
- Wang, Yaomin, Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
- Guo, Qi, Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
- Qian, Changyun, FibroGen, Shanghai, China
- Wu, Yiqing, FibroGen, Shanghai, China
- Pan, Shuting, FibroGen, Shanghai, China
- Chen, Jianghua, Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
Background
Anemia is associated with increased morbidity/mortality in chronic kidney disease (CKD) patients. Roxadustat (RXD) stimulates erythropoiesis & has demonstrated effectiveness for anemia treatment. We conducted a real-world clinical study on the safety/effectiveness of RXD for CKD-associated anemia (CKD-anemia) treatment & its effect on quality of life (QOL).
Methods
This phase 4, prospective, clinical study enrolled patients aged ≥18 years with CKD-anemia (with or without dialysis) in 61 centers in China. Patients received a starting dose of 70–120-mg RXD orally thrice a week for 52 weeks. Primary & secondary outcomes were long-term safety & effectiveness. Safety assessments included the number of patients with treatment-emergent adverse events (TEAEs). Effectiveness was assessed by hemoglobin (Hb) change from baseline & percentage of patients with mean Hb >100 g/L. QOL was assessed by changes from baseline at 24 weeks in the Short Form (SF)-36 Vitality (V) & Physical Functioning (PF) subscales & self-reported Rapid Assessment of Physical Activity (RAPA) scores.
Results
Of 2024 patients enrolled, 1830 were RXD-naïve, 193 were previously RXD-treated, & 1 was unknown. In total 2021 (99.9%) received ≥1 RXD dose (hemodialysis: n=851 [42.1%]; peritoneal dialysis: n=676 [33.4%]; non-dialysis-dependent: n=494 [22.4%]) & 1592 (78.8%) completed the study. The mean±standard deviation (SD) age was 50.2±13.5 years, the weekly RXD dose was 254.13±103.16 mg & 53.8% were male. In total 1643/2021 patients (81.3%) reported TEAEs (hyperkalemia, 15.4%; upper respiratory tract infection, 10.0%; peripheral oedema, 5.2%) & 219 (10.8%) patients had drug-related TEAEs (nausea, 1.3%; hypertension, 1.0%; insomnia, 0.9%). TEAEs led to death in 38 patients (1.9%), but none were deemed related to RXD. In RXD-naïve patients (n=1804), the mean±SD Hb increased by 14.28±0.38 g/L over weeks 36–52. From weeks 24–52 the mean percentage of patients with Hb >100 g/L was 86.3% in RXD-naïve patients & 85.9% in treated patients (baseline, 45.6% & 61.1%). There were no changes in QOL at 24 weeks.
Conclusion
RXD had tolerable safety & increased Hb to >100 g/L in >85% of patients over 24–52 weeks; these results support RXD treatment for CKD-anemia patients in a real-world setting.