Abstract: FR-PO1070

DIALOGUE Phase 2 Extension Studies of BAY 85-3934, Molidustat, a HIF-PH Inhibitor with Daily Oral Treatment in Anemic Subjects with CKD

Session Information

Category: Dialysis

  • 605 Dialysis: Anemia and Iron Metabolism

Authors

  • Akizawa, Tadao, Showa University School of Medicine, Tokyo, Japan
  • Macdougall, Iain C., King's College Hospital, London, United Kingdom
  • Berns, Jeffrey S., University of Pennsylvania School of Medicine , Philadelphia, Pennsylvania, United States
  • Bernhardt, Thomas, Bayer AG, 13353 Berlin, Germany
  • Krueger, Thilo, Bayer AG, 13353 Berlin, Germany
  • Taguchi, Megumi, Bayer Yakuhin, Ltd., Osaka, Japan
  • Ogura, Eriko, Bayer Yakuhin, Ltd., Osaka, Japan
  • Iekushi, Kazuma, Bayer Yakuhin, Ltd, Osaka, Japan
Background

Renal anemia is one of the most frequent complications of chronic kidney disease (CKD). Traditionally renal anemia is treated with erythropoiesis stimulating agents. The Hypoxia-inducible factor (HIF)-prolyl hydroxylase (PH) inhibitor, molidustat (BAY 85-3934), is developed for the oral treatment of anemia in subjects with CKD.

Methods

The clinical program included 3 randomized, multicenter main studies and 2 controlled, parallel group, open-label, multicenter extension studies, one in non-dialysis and one in dialysis subjects with anemia associated with CKD. Subjects enrolled in the main studies were planned to enter the 2 extension studies to prove long-term safety and efficacy of molidustat for a period of up to 36 months as measured by the change from baseline to post-baseline time points in Hb levels.

Results

In the hemodialysis study, mean Hb values at baseline were similar in the molidustat group (10.40 g/dL) and in the epoetin group (10.52 g/dL). Mean (SD) Hb values during treatment were 10.52 (0.557) g/dL in the molidustat group and 10.37 (0.471) g/dL in the epoetin group. Similar rates of subjects reported a TEAE in the molidustat group (91.2%) compared with the epoetin group (93.3%). In the non-dialysis study, mean Hb values at baseline were similar in the molidustat group (11.28 g/dL) and in the darbepoetin group (11.08 g/dL). Mean (SD) Hb values during treatment were 11.10 (0.508) g/dL in the molidustat group and 10.98 (0.571) g/dL in the darbepoetin group. Similar rates of subjects reported a TEAE in the molidustat group (85.6%) compared with the darbepoetin group (85.7%).

Conclusion

The oral HIF-PH inhibitor, molidustat may offer potential benefits for managing anemia in both dialysis and non-dialysis subjects. Future Phase 3 studies of larger size will be executed to further assess the effects of molidustat.

Funding

  • Commercial Support