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Abstract: TH-PO892

A Randomized Controlled Trial to Evaluate the Efficacy of Roxadustat Dosing Regimens in Patients with CKD and Anemia on Dialysis

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Tu, Yan, Institute of Nephrology, Zhongda Hospital, Southeast University School of Medicine, Nanjing, Jiangsu, China
  • Liu, Bi-Cheng, Institute of Nephrology, Zhongda Hospital, Southeast University School of Medicine, Nanjing, Jiangsu, China
  • Huang, Cuihua, Medical Affairs, FibroGen (China) Medical Technology Development Co., Ltd., Beijing, Beijing, China
  • Yuchen, Zhang, Medical Affairs, FibroGen (China) Medical Technology Development Co., Ltd., Beijing, Beijing, China
  • Pan, Shuting, Clinical Biometrics, FibroGen (China) Medical Technology Development Co., Ltd., Beijing, Beijing, China
  • Niu, Wei, Clinical Development, FibroGen (China) Medical Technology Development Co., Ltd., Beijing, Beijing, China
Background

It is unknown how roxadustat dose frequency reduction impacts hemoglobin (Hb) maintenance in patients with CKD anemia. We report here on Part 2 of a Phase 4 study (NCT04059913) which evaluated efficacy (Hb maintenance) and safety of three roxadustat dosing frequencies (once weekly [QW], twice a week [BIW], thrice a week [TIW]) in Chinese CKD anemia patients on dialysis after Hb correction in Part 1 (2023 ASN TH-PO981).

Methods

Eligible patients from Part 1 (Weeks 19 and 21 Hb ≥105 g/L and 4-week change in Hb >−10 g/L) were randomized to roxadustat QW, BIW or TIW. Frequency increases were permitted if needed. Non-inferiority testing was used for full analysis set (FAS) and per protocol set (PPS) analyses: 1) BIW vs. TIW and 2) QW vs. TIW (non-inferiority margin [NIM]=10 g/L). The primary endpoint was least-squares mean (LSM) Hb averaged at Weeks 33–37.

Results

A total of 178 patients were included: 175 patients in FAS (TIW: 61; BIW: 59; QW: 55) and 169 patients in PPS (TIW: 60; BIW: 57; QW: 52). Demographics were comparable across arms. Mean (SD) baseline Hb were 115.0 (6.1) g/L (TIW), 115.4 (6.5) g/L (BIW) and 114.4 (5.7) g/L (QW). In the PPS, the Hb LSMs [95% CI] at weeks 33-37 were 108.3 [105.7, 110.9] g/L (TIW), 107.1[104.4, 109.7] g/L (BIW), and 106.3 [103.6, 108.9] g/L (QW) (differences: −1.2 [95% CI: −4.4, 1.9] g/L [BIW vs. TIW]; −2.0 [95% CI: −5.3, 1.2] g/L [QW vs. TIW]). The lower 95% CI limit was >−10 g/L (NIM margin) for each comparison. FAS and PPS results were consistent. Around 90–95% TIW patients maintained TIW dosing, while 69.5–76.3% BIW and only 30.9–32.7% QW patients maintained their dose frequency. TEAEs occurred in 81.1% (TIW), 78.3% (BIW), and 63.4% (QW) of patients.

Conclusion

Non-inferiority was established between roxadustat BIW vs. TIW and QW vs. TIW. However, a proportion of patients in QW and BIW arms required dose frequency increases to maintain Hb. The clinical benefit of reducing roxadustat dose frequency is limited and should be carefully evaluated.

Funding

  • Commercial Support – FibroGen (China) sponsored this study