Kidney Week

Abstract: TH-PO227

Efficacy and Safety of Daprodustat on Anemia Management in Japanese Hemodialysis Patients Not Using Erythropoiesis-Stimulating Agents

Session Information

• Anemia and Iron Metabolism: Clinical
  October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Dialysis

• 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

• Fujii, Taku, GlaxoSmithKline, Tokyo, Japan

Taku Fujii,

• Tsubakihara, Yoshiharu, Graduate School of Health Care Science, Jikei Institute, Yodogawa-ku, Osaka, Japan

Yoshiharu Tsubakihara,

• Akizawa, Tadao, Showa University School of Medicine, Tokyo, Japan

Tadao Akizawa,

• Nangaku, Masaomi, the University of Tokyo School of Medicine, Tokyo, Japan

Masaomi Nangaku,

• Onoue, Tomohiro, GlaxoSmithKline, Tokyo, Japan

Tomohiro Onoue,

• Yonekawa, Taeko, GlaxoSmithKline, Tokyo, Japan

Taeko Yonekawa,

• Endo, Yukihiro, GlaxoSmithKline, Tokyo, Japan

Yukihiro Endo,

• Cobitz, Alexander Ralph, GlaxoSmithKline, Tokyo, Japan

Alexander Ralph Cobitz,

Background

This Phase 3, open-label, non-comparative, multi-center study (funded by GlaxoSmithKline) examined the efficacy and safety of daprodustat (Hypoxia Inducible Factor-Prolyl Hydroxylase Inhibitor) over the 24 weeks in 28 Japanese hemodialysis (HD) subjects not using erythropoiesis stimulating agents (ESA).

Methods

Subjects on newly started dialysis or maintenance dialysis with hemoglobin (Hgb) of 8.0-<10.0 g/dL not using ESA were enrolled to receive daily oral daprodustat. After the first 4 weeks of the fixed starting dose of 4 mg, doses were adjusted monthly to achieve a Hgb target of 10.0–12.0 g/dL over the 24 weeks, utilizing doses ranging from 1-24 mg. The primary endpoint was to evaluate Hgb at Week 4. All subjects received the full ophthalmologic examinations (best corrected visual acuity, intraocular pressure, an anterior segment exam, and a fundoscopic exam) at baseline, Week 12 and the end of study.

Results

The mean baseline Hgb value was 9.10 g/dL. After the first 4 weeks, the mean change in Hgb from baseline was 0.79 g/dL (95%CI: 0.53, 1.05). No subjects experienced a rapid Hgb increase, defined as > 2 g/dL over the first 4 weeks. The mean Hgb value increased and reached the target range (10-12 g/dL) at Week 8 (10.76 g/dL), and was maintained within the target range at Week 24 (11.12 g/dL). At Week 24, 23 subjects (82%) had a Hgb value within the target range, and 18 (64%) subjects reached the lower target Hgb value without a dose adjustment. Ninety-two percentage of on-therapy AEs were reported as either mild or moderate in severity. There were no AEs leading to withdrawal/discontinuation of study treatment and no pre-defined ocular AEs of special interest were reported from the full ophthalmologic exam.

Conclusion

Daprodustat 4mg safely and effectively increased Hgb over the initial first 4 weeks of treatment. Daprodustat had an ability to achieve and maintain Hgb within target range and was generally well tolerated over the 24-week of treatment.

Funding

• Commercial Support –