A Phase III, Double Blind, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
Sponsor study identifier
interventional
323
1 country
28
Study Start
February 14, 2018
Actual (reported)Primary Completion
December 12, 2018
Actual (reported)Study Completion
July 16, 2019
Actual (reported)For hemodialysis subjects currently receiving ESAs with anemia associated with chronic kidney disease, demonstrate non-inferiority of MT-6548 compared to darbepoetin alfa using Hb value and evaluate long-term safety of MT-6548.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 16, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 14, 2018
Actual (reported)February 14, 2018
Actual (reported)February 20, 2018
Actual (reported)December 12, 2018
Actual (reported)July 16, 2019
Actual (reported)April 12, 2021
Actual (reported)Mean Hb Level of Week 20 and Week 24
Up to Week 24
Mean Hb Level of Week 48 and Week 52
Up to Week 52
Hb Level at Each Assessment Time Point
Up to Week 52
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Up to Week 52
Research site
Aichi, Japan
Research site
Chiba, Japan
Research site
Fukui, Japan
Research site
Fukuoka, Japan
Research site
Fukushima, Japan
Research site
Gunma, Japan
Research site
Hiroshima, Japan
Research site
Nangaku M, Kondo K, Ueta K, Kokado Y, Kaneko G, Matsuda H, Kawaguchi Y, Komatsu Y. Efficacy and safety of vadadustat compared with darbepoetin alfa in Japanese anemic patients on hemodialysis: a Phase 3, multicenter, randomized, double-blind study. Nephrol Dial Transplant. 2021 Aug 27;36(9):1731-1741. doi: 10.1093/ndt/gfab055.
Nangaku M, Ueta K, Nishimura K, Sasaki K, Hashimoto T. Factors affecting responsiveness of vadadustat in patients with anemia associated with chronic kidney disease: a post-hoc subgroup analysis of Japanese phase 3 randomized studies. Clin Exp Nephrol. 2024 May;28(5):391-403. doi: 10.1007/s10157-023-02432-z. Epub 2024 Mar 26.
General Manager
Tanabe Pharma Corporation
323 participants (actual enrollment reported by the registry).
First Submitted
February 14, 2018
First Posted
February 20, 2018
Study Start
February 14, 2018
Actual (reported)Oral tablet
Contact the study team to confirm eligibility.
Hokkaido, Japan
Research site
Hyōgo, Japan
Research site
Ibaraki, Japan
Research site
Kagawa, Japan
Research site
Kagoshima, Japan
Research site
Kanagawa, Japan
Research site
Kumamoto, Japan
Research site
Kyoto, Japan
Research site
Miyagi, Japan
Research site
Nagano, Japan
Research site
Nagasaki, Japan
Research site
Okayama, Japan
Research site
Okinawa, Japan
Research site
Osaka, Japan
Research site
Ōita, Japan
Research site
Saitama, Japan
Research site
Shiga, Japan
Research site
Shizuoka, Japan
Research site
Tokushma, Japan
Research site
Tokyo, Japan
Research site
Yamagata, Japan
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Primary Completion
December 12, 2018
Actual (reported)Study Completion
July 16, 2019
Actual (reported)Last Updated
April 6, 2026
Results First Posted
April 12, 2021
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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