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Abstract Background and Aims Clinical practice guidelines recommend initiating anemia treatment in non-dialysis (ND) chronic kidney disease (CKD) patients when hemoglobin (Hb) levels fall below 100 g/L. However, in real-world clinical practice, treatment is often delayed until Hb levels drop below 90 g/L. This secondary analysis of the ROXSTAR Registry (ChiCTR2100046322) aimed to evaluate Hb target achievement with 52-week roxadustat use in ND-CKD patients, stratified by baseline Hb levels. Method This secondary analysis utilized data from the ROXSTAR Registry. ND-CKD patients who received roxadustat and had at least one post-baseline Hb measurement were included. Oral supplemental iron could be administered at any time according to clinical practice, while intravenous iron was administered if clinically indicated per investigator's judgement. Outcomes included the proportion of patients achieving mean Hb within 100–130 g/L and changes from baseline (CFB) in Hb averaged over weeks 24–52, stratified by baseline Hb subgroups (<90 g/L, ≥90 g/L); CFB in iron metabolism parameters (serum ferritin [SF], transferrin saturation [TSAT], serum iron, total iron binding capacity [TIBC], transferrin) and roxadustat weekly dose by visit were also evaluated by subgroup. Results Overall, 490 ND-CKD patients (baseline Hb <90 g/L: 146; baseline Hb ≥90 g/L: 344) were included (196 male [40.0%]), with a mean ± standard deviation age of 55.0 ± 14.0 years. The overall mean baseline Hb was 95.3 ± 12.2 g/L (baseline Hb < 90 g/L: 80.5 ± 8.0 g/L; baseline Hb ≥ 90 g/L: 101.6 ± 7.3 g/L). Patients with baseline Hb <90 had lower SF (median: 109.7 µg/L vs. 119.1 µg/L), lower TSAT (21.8% vs. 26.3%), and a higher proportion of elevated C-reactive protein (19.2% vs. 13.1%), compared to those with baseline Hb ≥90 g/L (Table 1). Overall, 84.8% (95% CI: 81.1%, 88.6%) of patients achieved mean Hb levels within 100–130 g/L, with higher achieving Hb target rates in the baseline Hb ≥90 g/L group (88.3% [95% CI: 84.4%, 92.3%] vs. 76.6% [95% CI: 68.6%, 84.6%]). Patients with Hb<90 g/L demonstrated greater Hb CFB (27.0 [95% CI: 24.6, 29.3] g/L vs. 11.2 [95% CI: 10.0, 12.5] g/L). During treatment, 54.7% of patients received iron therapy, with higher utilization in the baseline Hb <90 g/L group (64.4% vs. 50.6%) (Table 1). Patients with baseline Hb<90 g/L experienced larger declines in SF (CFB: −63.6 µg/L vs. −35.6 µg/L at week 24; −46.3 µg/L vs. −35.6 µg/L at week 52), and greater increases in TSAT (CFB: 3.4% vs. 0.1% at week 24; 6.5% vs. 0.0% at week 52), similar increased trend was observed for serum iron, TIBC and transferrin (Table 2). Roxadustat mean weekly dose was higher for patients with baseline Hb <90 g/L (250.9 ± 82.7 mg vs. 193.9 ± 82.8 mg): it started at 261.8 ± 63.0 mg, slightly decreased to 239.7 ± 104.9 mg at week 24, and then slightly increased to 245.8 ± 101.3 mg at week 52; while for patients with baseline Hb ≥90 g/L, it started at 227.4 ± 69.2 mg, decreased to 180.3 ± 98.2 mg at weeks 24, then increased to 192.5 ± 102.8 mg at week 52. Conclusion Roxadustat effectively corrected anemia, maintained target Hb levels, and improved iron utilization in ND-CKD patients in real-world settings, irrespective of baseline Hb levels. However, fewer patients with baseline Hb <90 g/L achieved target Hb levels despite higher roxadustat doses and iron use, highlighting the potential benefits of earlier anemia treatment initiation when Hb levels are ≥90 g/L.
Published in: Nephrology Dialysis Transplantation
Volume 40, Issue Supplement_3