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Abstract: TH-PO978

Arterial and Venous Thromboembolic Events in Patients With Anemia of Dialysis-Dependent CKD Treated With Roxadustat: Exploratory Post Hoc Analysis

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Hamano, Takayuki, Nagoya Shiritsu Daigaku Daigakuin Igaku Kenkyuka Igakubu, Nagoya, Aichi, Japan
  • Yamaguchi, Yusuke, Astellas Pharma Global Development Inc, Northbrook, Illinois, United States
  • Goto, Kashia, Astellas Seiyaku Kabushiki Kaisha, Chuo-ku, Tokyo, Japan
  • Jiletcovici, Alina, Astellas Pharma US Inc, Northbrook, Illinois, United States
  • Martin, Shaka, Astellas Pharma US Inc, Northbrook, Illinois, United States
  • Dellanna, Frank, MVZ DaVita Rhein-Ruhr GmbH, Düsseldorf, Germany
  • Akizawa, Tadao, Showa Daigaku, Shinagawa-ku, Tokyo, Japan
  • Barratt, Jonathan, University of Leicester, Leicester, Leicestershire, United Kingdom
Background

Venous and arterial thromboembolic events (TEs) are of interest in patients with anemia of DD-CKD. We evaluated clinical characteristics of patients with TEs treated with roxadustat, an oral medication.

Methods

We performed post hoc analyses separately using 2 pooled data sets of patients with DD-CKD anemia who received roxadustat in global phase 3 studies (PYRENEES, SIERRAS, HIMALAYAS, ROCKIES) and Japanese phase 3 studies with Hb correction and/or ESA conversion. Endpoints were the incidence of TEs with onset before and after Week 12. Risk factors for baseline characteristics potentially associated with TEs were identified by Cox regression analyses. Nested case-control analyses explored relationships between TE incidence and last-known laboratory parameters using conditional logistic models with matched pairs of case-control data. Matching variables were selected from Cox regression analysis results.

Results

Cox regression analysis of global studies identified age, hemodialysis, race, history of thromboembolism, CV event and/or diabetes, high BMI, low TSAT, and high baseline CRP as associated with increased risk of TE before and/or after Week 12. Nested case-control analysis of global studies suggested the risk of TE increased with Hb rate of increase before Week 12 and with low Hb and low TSAT after Week 12 (Table). Similar trends were observed in the analysis of studies in Japan.

Conclusion

TEs in patients with anemia of CKD are complex; these results should be interpreted cautiously as hypothesis-generating. Hb levels ≤10 g/dL, Hb rate of change and iron deficiency may augment the risk of TEs in patients with anemia of DD-CKD treated with roxadustat.

Funding

  • Commercial Support