ASN's Mission

To create a world without kidney diseases, the ASN Alliance for Kidney Health elevates care by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on X

Kidney Week

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

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.