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Trial record 1 of 1 for:    MT-6548-J01
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Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

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ClinicalTrials.gov Identifier: NCT03329196
Recruitment Status : Active, not recruiting
First Posted : November 1, 2017
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

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


Condition or disease Intervention/treatment Phase
Anemia; Non-dialysis Dependent Chronic Kidney Disease Drug: MT-6548 Drug: Darbepoetin alfa Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Open-label, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
Actual Study Start Date : October 30, 2017
Actual Primary Completion Date : January 8, 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MT-6548 Drug: MT-6548
Oral tablet
Other Names:
  • vadadustat
  • AKB-6548

Active Comparator: Darbepoetin alfa Drug: Darbepoetin alfa
Subcutaneous




Primary Outcome Measures :
  1. Mean Hb level of Week 20 and Week 24 [ Time Frame: Up to Week 24 ]

Secondary Outcome Measures :
  1. Mean Hb level of Week 48 and Week 52 [ Time Frame: Up to Week 52 ]
  2. Hb level at each assessment time point [ Time Frame: Up to Week 52 ]
  3. Proportion of subjects with Hb level at each assesment time point within the target range during the treatment period [ Time Frame: Up to Week 52 ]
  4. Time to reach the target Hb range in correction group only [ Time Frame: Up to Week 52 ]
  5. Rate of increase in Hb level in correction group only [ Time Frame: Up to Week 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329196


Locations
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Japan
Research site
Aichi, Japan
Research site
Chiba, Japan
Research site
Fukui, Japan
Research site
Fukuoka, Japan
Research site
Fukushima, Japan
Research site
Gunma, Japan
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Hiroshima, Japan
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Hokkaido, Japan
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Hyogo, Japan
Research site
Ibaraki, Japan
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Kagoshima, Japan
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Kanagawa, Japan
Research site
Kochi, Japan
Research site
Kumamoto, Japan
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Kyoto, Japan
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Miyagi, Japan
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Nagano, Japan
Research site
Nagasaki, Japan
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Nara, Japan
Research site
Niigata, Japan
Research site
Oita, Japan
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Okayama, Japan
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Okinawa, Japan
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Osaka, 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
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: General Manager Mitsubishi Tanabe Pharma Corporation

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT03329196     History of Changes
Other Study ID Numbers: MT-6548-J01
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics