Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan
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
1 other identifier
interventional
323
1 country
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2018
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2018
CompletedStudy Start
First participant enrolled
February 14, 2018
CompletedFirst Posted
Study publicly available on registry
February 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2019
CompletedResults Posted
Study results publicly available
April 12, 2021
CompletedJanuary 7, 2026
December 1, 2025
10 months
February 14, 2018
March 15, 2021
December 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Hb Level of Week 20 and Week 24
Up to Week 24
Secondary Outcomes (3)
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
Study Arms (2)
MT-6548
EXPERIMENTALDarbepoetin alfa
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of CKD
- Receiving hemodialysis or hemodiafiltration 3 times a week for more than 12 weeks prior to the screening period, excluding receiving home dialysis or combination of peritoneal dialysis.
- Being treated with ESAs for the recent 8 weeks prior to the screening period
- Mean of the two screening Hb levels closest in time to the baseline visit is ≥9.5 g/dL and ≤12.0 g/dL
- Fluctuation between the two Hb levels closest in time to the baseline visit during the screening period less than 1.5 g/dL
- Serum ferritin ≥ 100 ng/mL, or TSAT ≥20% during the screening period
- Folate and vitamin B12 ≥ lower limit of normal during the screening period
You may not qualify if:
- Anemia due to a main cause other than CKD: sickle cell disease, myelodysplastic syndrome, bone marrow fibrosis, hematologic malignancy, hemolytic anemia, thalassemia, or pure red cell aplasia
- Active bleeding or recent blood loss within 8 weeks prior to the screening period
- RBC transfusion within 8 weeks prior to the screening period
- Received testosterone enanthate or mepitiostane within 8 weeks prior to the screening period
- AST, ALT, or total bilirubin \>2.5 x upper limit of normal during the screening period
- Uncontrolled hypertension (diastolic blood pressure \>110 mm Hg or systolic blood pressure \>180 mm Hg) at the first day of the screening period and Day 1
- Ophthalmic examinations during the screening period correspond to either of the following criteria;
- No available fundal findings
- Findings indicating the presence of active fundal disease
- Severe heart failure (New York Heart Association Class IV)
- Cerebrovascular disorder or acute coronary syndrome (hospitalization due to unstable angina or myocardial infarction), requiring hospitalization due to urgent percutaneous intervention for coronary or heart failure within 12 weeks prior to the screening period
- New onset or recurrent event of deep vein thrombosis or pulmonary embolism within 12 weeks prior to the screening period
- Current or history of hemosiderosis or hemochromatosis
- History of prior organ transplantation or scheduled organ transplant, or prior transplantation of hematopoietic stem cell or bone marrow
- Males and females of childbearing potential who are unwilling to use an acceptable method of contraception during the designated period (Males: during the study and 90 days after the last dose, females: during study and 30 days after the last dose)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
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
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
Related Publications (3)
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.
PMID: 33650630RESULTNangaku 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.
PMID: 38530490DERIVEDNatale 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.
PMID: 36005278DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials, Information Desk
- Organization
- Tanabe Pharma Corporation
Study Officials
- STUDY DIRECTOR
General Manager
Tanabe Pharma Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2018
First Posted
February 20, 2018
Study Start
February 14, 2018
Primary Completion
December 12, 2018
Study Completion
July 16, 2019
Last Updated
January 7, 2026
Results First Posted
April 12, 2021
Record last verified: 2025-12