Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Not Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan

NCT03461146 | Completed Phase 3 Results FDA Drug

• 1 other identifier: MT-6548-J04
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 16

Brief Summary

For hemodialysis subjects not receiving ESAs with anemia associated with chronic kidney disease, evaluate Hb correction and maintenance effect and safety of MT-6548.

Conditions

Anemia; Hemodialysis Dependent Chronic Kidney Disease

Outcome Measures

Primary Outcomes (5)

• 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

  Up to Week 24

• Rate of Increase in Hb Level

  Up to Week 6

Study Arms (1)

MT-6548

EXPERIMENTAL

Drug: MT-6548

Interventions

MT-6548 DRUG

Oral tablet

Also known as: vadadustat, AKB-6548

MT-6548

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• Not being treated with ESAs or if being treated with ESAs, leave defined interval between last ESAs administration and the first day of the screening period
• Mean of the two screening Hb levels closest in time to the baseline visit is ≥8.0 g/dL and \<10.0 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)

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (16)

Research site

Aichi, Japan

Location

Research site

Chiba, Japan

Location

Research site

Fukushima, Japan

Location

Research site

Gunma, Japan

Location

Research site

Hokkaido, Japan

Location

Research site

Hyōgo, Japan

Location

Research site

Ibaraki, Japan

Location

Research site

Kagoshima, Japan

Location

Research site

Nagano, Japan

Location

Research site

Okayama, Japan

Location

Research site

Okinawa, Japan

Location

Research site

Osaka, Japan

Location

Research site

Saitama, Japan

Location

Research site

Shiga, Japan

Location

Research site

Shizuoka, Japan

Location

Research site

Yamagata, Japan

Location

Related Publications (1)

• Nangaku M, Kondo K, Takabe S, Ueta K, Tandai T, Kawaguchi Y, Komatsu Y. A phase 3, open-label, single-arm study of vadadustat for anemia in chronic kidney disease for Japanese patients on hemodialysis not receiving erythropoiesis-stimulating agents. Ther Apher Dial. 2022 Feb;26(1):45-54. doi: 10.1111/1744-9987.13699. Epub 2021 Jun 28.

  PMID: 34115437 RESULT

MeSH Terms

Conditions

Anemia

Interventions

vadadustat

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

+81-3-5960-9608 Japanese only

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 9, 2018
• Study Start: March 5, 2018
• Primary Completion: December 3, 2018
• Study Completion: December 17, 2018
• Last Updated: January 7, 2026
• Results First Posted: May 7, 2021

Record last verified: 2025-12

Locations

JP (16)