A Phase III, Open-label, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
Sponsor study identifier
interventional
304
1 country
31
Study Start
October 30, 2017
Actual (reported)Primary Completion
January 8, 2019
Actual (reported)Study Completion
August 9, 2019
Actual (reported)For Non-dialysis subjects 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. For subjects not currently receiving ESAs, evaluate Hb correction and maintenance effect of MT-6548 and for subjects currently receiving ESAs, evaluate Hb conversion and maintenance effect of MT-6548
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 9, 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.
October 30, 2017
Actual (reported)October 30, 2017
Actual (reported)November 1, 2017
Actual (reported)January 8, 2019
Actual (reported)August 9, 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
Time to Reach the Target Hb Range in Correction Group Only
Up to Week 52
Rate of Increase in Hb Level in Correction Group Only
Up to Week 6
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, Kokado Y, Ueta K, Kaneko G, Tandai T, Kawaguchi Y, Komatsu Y. Phase 3 Randomized Study Comparing Vadadustat with Darbepoetin Alfa for Anemia in Japanese Patients with Nondialysis-Dependent CKD. J Am Soc Nephrol. 2021 Jul;32(7):1779-1790. doi: 10.1681/ASN.2020091311. Epub 2021 Apr 21.
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
304 participants (actual enrollment reported by the registry).
First Submitted
October 30, 2017
First Posted
November 1, 2017
Study Start
October 30, 2017
Actual (reported)Contact the study team to confirm eligibility.
Hokkaido, Japan
Research site
Hyōgo, Japan
Research site
Ibaraki, Japan
Research site
Kagoshima, Japan
Research site
Kanagawa, Japan
Research site
Kochi, Japan
Research site
Kumamoto, Japan
Research site
Kyoto, Japan
Research site
Miyagi, Japan
Research site
Nagano, Japan
Research site
Nagasaki, Japan
Research site
Nara, Japan
Research site
Niigata, Japan
Research site
Okayama, Japan
Research site
Okinawa, Japan
Research site
Osaka, Japan
Research site
Ōita, Japan
Research site
Saga, Japan
Research site
Saitama, Japan
Research site
Shiga, Japan
Research site
Shizuoka, Japan
Research site
Tokyo, Japan
Research site
Toyama, Japan
Research site
Yamanashi, 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
January 8, 2019
Actual (reported)Study Completion
August 9, 2019
Actual (reported)Last Updated
April 6, 2026
Results First Posted
April 12, 2021
Record last verified: 2026-03
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