A Phase III, Open-label Study of MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
Sponsor study identifier
interventional
42
1 country
17
Study Start
January 3, 2018
Actual (reported)Primary Completion
November 22, 2018
Actual (reported)Study Completion
December 20, 2018
Actual (reported)To evaluate the efficacy and safety of MT-6548 in peritoneal dialysis subjects with anemia associated with chronic kidney disease
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 20, 2018
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.
December 27, 2017
Actual (reported)January 3, 2018
Actual (reported)January 18, 2018
Actual (reported)November 22, 2018
Actual (reported)December 20, 2018
Actual (reported)July 6, 2021
Actual (reported)Mean Hb Level of Week 20 and Week 24
Up to Week 24
Hb Level at Each Assessment Time Point
Up to Week 24
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Up to Week 24
Time to Reach the Target Hb Range in Correction Group Only
Up to Week 24
Rate of Increase in Hb Level in Correction Group Only
Up to Week 6
Research site
Aichi, Japan
Research site
Chiba, Japan
Research site
Fukuoka, Japan
Research site
Fukushima, Japan
Research site
Gunma, Japan
Research site
Hokkaido, Japan
Research site
Hyōgo, Japan
Research site
Nangaku M, Kondo K, Takabe S, Ueta K, Kaneko G, Otsuka M, Kawaguchi Y, Komatsu Y. Vadadustat for anemia in chronic kidney disease patients on peritoneal dialysis: A phase 3 open-label study in Japan. Ther Apher Dial. 2021 Oct;25(5):642-653. doi: 10.1111/1744-9987.13611. Epub 2020 Dec 29.
General Manager
Tanabe Pharma Corporation
42 participants (actual enrollment reported by the registry).
First Submitted
December 27, 2017
First Posted
January 18, 2018
Study Start
January 3, 2018
Actual (reported)Contact the study team to confirm eligibility.
Ibaraki, Japan
Research site
Kagoshima, Japan
Research site
Kanagawa, Japan
Research site
Kyoto, Japan
Research site
Nagano, Japan
Research site
Nara, Japan
Research site
Okayama, Japan
Research site
Okinawa, Japan
Research site
Shiga, Japan
Research site
Tokyo, Japan
Primary Completion
November 22, 2018
Actual (reported)Study Completion
December 20, 2018
Actual (reported)Last Updated
April 6, 2026
Results First Posted
July 6, 2021
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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