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Kidney Week

Abstract: TH-PO1157

A Randomized, Controlled, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Lower Starting Dose Roxadustat for Anemia Treatment in Patients with CKD Not on Dialysis

Session Information

  • Late-Breaking Posters
    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

  • Li, Ping, First Medical Center of Chinese PLA General Hospital, Nephrology Institute of the Chinese People's Liberation Army, National Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Kidney Disease Research, Beijing, China
  • Cai, Guangyan, First Medical Center of Chinese PLA General Hospital, Nephrology Institute of the Chinese People's Liberation Army, National Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Kidney Disease Research, Beijing, China
  • Sun, Xuefeng, First Medical Center of Chinese PLA General Hospital, Nephrology Institute of the Chinese People's Liberation Army, National Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Kidney Disease Research, Beijing, China
  • Wu, Yiqing, FibroGen (China) Medical Technology Co., Ltd., Shanghai, China
  • Huang, Cuihua, FibroGen (China) Medical Technology Co., Ltd., Shanghai, China
  • Pan, Shuting, FibroGen (China) Medical Technology Co., Ltd., Shanghai, China
  • Chen, Xiangmei, First Medical Center of Chinese PLA General Hospital, Nephrology Institute of the Chinese People's Liberation Army, National Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Kidney Disease Research, Beijing, China
Background

Roxadustat is approved in China for chronic kidney disease (CKD)-associated anemia (CKD-anemia) treatment with and without dialysis. We assessed the non-inferiority of lower starting dose (LSD) roxadustat versus standard starting dose (SSD) for stage 3–5 CKD-anemia treatment without dialysis.

Methods

In this non-inferiority trial, patients were randomized (1:1) to a weight-based SSD (<60 kg: 70 mg three times per week [TIW]; ≥60 kg: 100 mg TIW) or LSD (<60 kg: 50 mg TIW; ≥60 kg: 70 mg TIW). Treatment was for 16 weeks (assessments every 2 weeks for 8 weeks, then every 4 weeks). The primary efficacy endpoint was the mean hemoglobin (Hb) change from baseline over weeks 12–16. Adverse events (AEs) were assessed during the treatment period and 4 weeks after completion.

Results

In total, 254 patients were randomized. The SSD (n=128) and LSD (n=126) groups had comparable baseline characteristics. The baseline Hb was 89.4 g/L (7.0) for LSD & 90.6g/L (6.7) for SSD. In the per protocol set (PPS) (n=226), the mean Hb change from baseline over 12–16 weeks was 21.6 g/L for LSD and 26.4 g/L for SSD (−4.78 g/L, 95% confidence interval [CI] −7.77 to −1.79 g/L [<−5 g/L non-inferiority margin]). In the PPS, 47.8% of the LSD patients achieved Hb 100–120 g/L over weeks 12–16 versus 47.7% for the SSD (odds ratio 1.158, 95% CI 0.671 to 1.996; P=0.60). The full analysis set (n=249) had similar results. The LSD group had significantly lower rates of change in Hb from baseline to weeks 4 (P=0.03), 8 (P=0.03), and 16 (P<0.01). There were 3 (2.4%) of the LSD & 2 (1.6%) of the SSD patients received rescue therapy . In the safety set (n=250), 68.0% of patients had treatment-emergent AEs (LSD 72.2%; SSD 63.7%). The proportions of treatment-emergent serious AEs (24.6% vs 10.5%) and drug-related AEs (4.0% vs 2.4%) were numerically higher with the LSD than the SSD.

Conclusion

Non-inferiority was not established for the LSD compared with the SSD in stage 3–5 CKD non-dialysis patients. The proportion of patients who achieved Hb 100–120 g/L over weeks 12–16 for both groups was similar; patients receiving the LSD had less Hb fluctuation. Both dosages were well tolerated, however, LSD did not show a better safety profile.

Funding

  • Commercial Support – Beijing Municipal Science & Technology Commission (Z191100007619054) and FibroGen China co-funded this study. This study was sponsored by the Chinese PLA General Hospital and FibroGen (China) Medical Technology Development Company Limited (FibroGen China).