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Abstract: PO2114

Roxadustat vs. Placebo or Epoetin Alfa Has No Clinically Meaningful Effect on Blood Pressure in Patients with Anemia of CKD

Session Information

Category: Hypertension and CVD

  • 1402 Hypertension and CVD: Clinical, Outcomes, and Trials

Authors

  • Chan, Tak Mao Daniel, University of Hong Kong, Queen Mary Hospital, Pok Fu Lam, Hong Kong SAR, China
  • Pecoits-Filho, Roberto, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
  • Rastogi, Anjay, University of California Los Angeles, Los Angeles, California, United States
  • Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States
  • Nolen, Jacqueline G., FibroGen Inc, San Francisco, California, United States
  • Zhong, Ming, FibroGen Inc, San Francisco, California, United States
  • Szczech, Lynda, FibroGen Inc, San Francisco, California, United States
  • Yu, Kin-Hung Peony, FibroGen Inc, San Francisco, California, United States
Background

Hypertension (HTN) is a leading cause of chronic kidney disease (CKD) and often worsens as CKD progresses. Erythropoiesis-stimulating agents have been associated with an increase in blood pressure (BP) and other cardiovascular risks. Roxadustat is an oral hypoxia–inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and improves iron metabolism. We evaluated the effect of roxadustat on BP in dialysis-dependent (DD) and non–dialysis-dependent (NDD) patients with anemia of CKD.

Methods

Pooled data from three, phase 3, randomized, placebo-controlled trials in NDD patients (n=4270), and three pivotal phase 3 randomized, active-controlled trials in DD patients (n=3880), including incident-dialysis-dependent (ID-DD; on dialysis for ≤4 mo; n=1526) and stable dialysis-dependent (SDD; on dialysis for >4 mo; n=2354) patients, were assessed. All DD patients and NDD patients (data censored after dialysis initiation [NDD-NDD]) were included. Mean change from baseline (CFB) in mean arterial pressure (MAP) averaged over Weeks 20–28 (NDD-NDD, SDD) and over weeks 8–12 (ID-DD); time to first exacerbation of hypertension (SBP ≥170 mmHg or DBP ≥110 mmHg and an increase from baseline ≥20 mmHg [SBP] or ≥15 mmHg [DBP]); and adjudicated hypertensive emergency were analyzed.

Results

In NDD-NDD, the least squares mean (LSM) (SE) difference between roxadustat and placebo in MAP (mmHg) was 0.67 (0.30) [95% CI: 0.09, 1.25]. Values for ID-DD and SDD patients were −0.35 (0.66) [95% CI: −1.65, 0.95] and −0.06 (0.42) [95% CI: −0.88, 0.76]. Hazard ratios (95% CI) for HTN exacerbation in NDD-NDD, ID-DD, and SDD patients were 1.12 (0.95, 1.32), 1.02 (0.84, 1.25), and 1.06 (0.93, 1.21). Follow-up adjusted incidence rates [events/100 patient-exposure year] of adjudicated hypertensive emergency were 1.1 and 1.1 in roxadustat- and placebo-treated NDD-NDD, 2.2 and 2.5 in the overall roxadustat- and epoetin-alfa treated DD, and 1.7 and 1.7 in the subgroup of ID-DD.

Conclusion

Pooled analyses of phase 3 data across a continuum of patients with CKD and anemia showed that roxadustat did not have any clinically meaningful effect on BP, HTN exacerbation, or hypertensive emergency vs. placebo in NDD-NDD patients and epoetin alfa in DD patients.

Funding

  • Commercial Support – Fibrogen, Inc.; AstraZeneca plc; Astellas Pharma Inc.