Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
NCT ID: NCT03329196
Last Updated: 2023-12-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
304 participants
INTERVENTIONAL
2017-10-30
2019-08-09
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MT-6548
MT-6548
Oral tablet
Darbepoetin alfa
Darbepoetin alfa
Subcutaneous
Interventions
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MT-6548
Oral tablet
Darbepoetin alfa
Subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Current or history of malignancy. History of malignancy with no recurrence for the recent 5 years is not an exclusion criterion
* 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)
* Females who are pregnant or breast feeding, or are predicted to be pregnant
20 Years
ALL
No
Sponsors
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Mitsubishi Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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General Manager
Role: STUDY_DIRECTOR
Mitsubishi Tanabe Pharma Corporation
Locations
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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
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
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MT-6548-J01
Identifier Type: -
Identifier Source: org_study_id