Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

NCT03329196 | Completed Phase 3 Results FDA Drug

• 1 other identifier: MT-6548-J01
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 31

Brief Summary

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

Conditions

Anemia; Non-dialysis Dependent Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Mean Hb Level of Week 20 and Week 24

  Up to Week 24

Secondary Outcomes (5)

• 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

Study Arms (2)

MT-6548

EXPERIMENTAL

Drug: MT-6548

Darbepoetin alfa

ACTIVE COMPARATOR

Drug: Darbepoetin alfa

Interventions

MT-6548 DRUG

Oral tablet

Also known as: vadadustat, AKB-6548

MT-6548

Darbepoetin alfa DRUG

Subcutaneous

Darbepoetin alfa

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
• eGFR \< 60 mL/min/1.73m\^2 during the screening period
• Not receiving dialysis for 8 weeks prior to the screening period, and not expected to start dialysis during the treatment period
• Correction group: Not being treated with ESAs for the recent 8 weeks prior to the screening period
• Conversion group: 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. Correction group: ≥8.0 g/dL and \< 11.0 g/dL Conversion group: ≥9.0 g/dL and ≤12.5 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) during 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 (31)

Research site

Aichi, Japan

Location

Research site

Chiba, Japan

Location

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Fukui, Japan

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Fukuoka, Japan

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Fukushima, Japan

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Gunma, Japan

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Hiroshima, Japan

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Hokkaido, Japan

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Hyōgo, Japan

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Ibaraki, Japan

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Kagoshima, Japan

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Kanagawa, Japan

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Kochi, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Miyagi, Japan

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Nagano, Japan

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Nagasaki, Japan

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Nara, Japan

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Niigata, Japan

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Okayama, Japan

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Okinawa, Japan

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Osaka, Japan

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Ōita, Japan

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Saga, Japan

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Saitama, Japan

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Shiga, Japan

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Shizuoka, Japan

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Tokyo, Japan

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Toyama, Japan

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Research site

Yamanashi, Japan

Location

Related Publications (3)

• 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.

  PMID: 33883252 RESULT

• 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.

  PMID: 38530490 DERIVED

• 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.

  PMID: 36005278 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

vadadustat; Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 1, 2017
• Study Start: October 30, 2017
• Primary Completion: January 8, 2019
• Study Completion: August 9, 2019
• Last Updated: January 7, 2026
• Results First Posted: April 12, 2021

Record last verified: 2025-12

Locations

JP (31)