Abstract: FR-PO0201
Association Between Erythrocyte Indices and Roxadustat Response in Patients with CKD and Anemia: ROXSTAR Registry Secondary Analysis
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
- Du, Xiaoying, Kidney Disease Center, The First Affiliated Hospital, Zhejiang University School of Medicine; Institute of Nephrology, Zhejiang University; Zhejiang Clinical Research Center of Kidney and Urinary System Disease, Hangzhou, Zhejiang, China
- Chen, Jianghua, Kidney Disease Center, The First Affiliated Hospital, Zhejiang University School of Medicine; Institute of Nephrology, Zhejiang University; Zhejiang Clinical Research Center of Kidney and Urinary System Disease, Hangzhou, Zhejiang, China
- Zheng, Dongwen, The Tenth Affiliated Hospital of Southern Medical University (Dongguan People’s Hospital), Dongguan, Guangdong, China
- Wu, Yiqing, FibroGen (China) Medical Technology Co., Ltd., Shanghai, China
Background
Erythrocyte indices (mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], MCH concentration [MCHC]) reflect red blood cells’ size and quality. Previous retrospective study showed a correlation between hemoglobin (Hb) increase and increased MCV in non-dialysis (ND) chronic kidney disease (CKD) patients receiving hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), and the anti-anemic effects may be influenced by baseline MCV values. To validate these findings across broader clinical settings, we conducted a second analysis of multicenter perspective study (ROXSTAR Registry: ChiCTR2100046322) both in dialysis-dependent (DD) and ND patients.
Methods
This secondary analysis included roxadustat-treated patients with ≥1 post-baseline MCV measurement. The outcomes included MCV, MCHC, MCH levels, changes from baseline (CFB) at week 24/52, and correlations between Δerythrocyte indices and Δhemoglobin (Hb) from baseline at week 24, stratified by dialysis status (DD, ND).
Results
Among 1998 patients (54% male; mean age 50.2±13.5 years; 1508 DD, 490 ND), baseline Hb was 97.3±13.9 g/L (11.9% <80 g/L). MCV, MCH and MCHC were 91.3±7.0 fL, 29.9±2.6 pg and 327.0±13.8 g/L, respectively. At week 52, MCV increased significantly (CFB: +1.9 fL [95%CI:1.5, 2.2]), with consistent trends in DD (+1.8 fL [1.4, 2.2]) and ND (+2.1 fL [1.4, 2.9]) subgroups. MCH rose (+0.6 pg [0.5, 0.7]), while MCHC mildly declined (-0.4 g/L [-1.1, 0.2]). No overall correlation existed between ΔHb and Δerythrocyte indices. However, ND-CKD patients exhibited a weak ΔHb-ΔMCV correlation (r=0.103, P=0.032). Roxadustat response (Hb≥10 g/L increase) was unaffected by baseline MCV or iron status (P>0.05 for all strata, Table 1).
Conclusion
MCV and MCH increased over 52-week roxadustat, with ND-CKD patients showing a marginal Hb-MCV association. Baseline MCV and iron status may not influence Hb response to roxadustat.
Funding
- Commercial Support – FibroGen (China)