Abstract: FR-PO0205
Roxadustat Response by Inflammation/Iron Status Subgroups in Patients on Peritoneal Dialysis and CKD-Related Anemia: Secondary Analysis of the NANLING Study
Session Information
- Anemia and Iron Metabolism
November 07, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Yu, Xueqing, Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, Guangdong, China
- Xu, Gang, Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei, China
- Zhang, Yuchen, FibroGen (China) Medical Technology Co., Ltd., Shanghai, Shanghai, China
- Zhang, Qionghua, FibroGen (China) Medical Technology Co., Ltd., Shanghai, Shanghai, China
Background
Clinical data on roxadustat response in peritoneal dialysis (PD) chronic kidney disease (CKD) patients with anemia remains limited. This secondary analysis of the NANLING (ChiCTR2100044799) aimed to evaluate the hemoglobin (Hb) response across subgroups of inflammation or iron during 24-week roxadustat therapy.
Methods
We analyzed data from 195 PD patients in the NANLING study who received roxadustat and had at least one post-baseline Hb measurement. Outcomes included the 24-week cumulative Hb response rate, defined as Hb≥110 g/L and a clinically significant Hb increase (≥10 g/L if baseline Hb >80 g/L; ≥20 g/L if baseline Hb≤80 g/L) and time-to-first Hb response. Subgroups were stratified by baseline inflammation (C-reactive protein [CRP] > upper limit of normal [ULN] vs ≤ULN) and iron status (replete: ferritin ≥100 μg/L + TSAT ≥20%; deficient: ferritin <100 μg/L or TSAT <20%). Changes in hepcidin, ferritin, transferrin saturation [TSAT], total iron-binding capacity [TIBC], soluble transferrin receptor [sTfR] were also assessed.
Results
The cohort (59.5% male; mean age 46.3±12.3 years) exhibited baseline Hb 98.1±10.7 g/L (57.4% <100 g/L). Most patients (74.4%) were iron-replete, and 66.7% (oral: 66.7%, intravenous: 0.5%) received iron therapy during study.
Overall, the Hb response rate was 90.3%; similar high across subgroups: 92.0% in patients with CRP>ULN and 89.7% in those with CRP≤ULN; 89.7% in iron-replete and 92.0% in iron-deficient patients. The median time-to-first Hb response was 29 days.
By week 24, hepcidin, ferritin and TSAT decreased from baseline (-58.5 ng/mL [95% CI -73.2 to -43.8], -81.2 μg/L [95%CI -112.9 to -49.6], and -3.9% [95% CI -6.8% to -1.1%], respectively), while TIBC, sTfR, and transferrin increased.
The average weekly roxadustat dose was 244.9±88.7 mg, similar across subgroups. The initial weekly doses decreased from 342.4±58.1 mg to 191.5±131.3 mg by week 16 and was maintained at ~ 200 mg by week 24.
Conclusion
Roxadustat achieved Hb response rates＞90% in PD patients with anemia, with consistent results across subgroups. The changes in iron parameters suggest roxadustat suppresses hepcidin and mediates iron utilization. Hb was corrected and maintained without dose escalation, supporting roxadustat as a viable alternative therapy for PD patients.
Funding
- Commercial Support – FibroGen (China)