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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03402386
Recruitment Status : Completed
First Posted : January 18, 2018
Results First Posted : July 6, 2021
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Description
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Brief Summary:
To evaluate the efficacy and safety of MT-6548 in peritoneal dialysis subjects with anemia associated with chronic kidney disease

Condition or disease Intervention/treatment Phase
Anemia; Peritoneal Dialysis Dependent Chronic Kidney Disease Drug: MT-6548 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Open-label Study of MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
Actual Study Start Date : January 3, 2018
Actual Primary Completion Date : November 22, 2018
Actual Study Completion Date : December 20, 2018

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Mean Hb Level of Week 20 and Week 24 [ Time Frame: Up to Week 24 ]
  2. Hb Level at Each Assessment Time Point [ Time Frame: Up to Week 24 ]
  3. Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period [ Time Frame: Up to Week 24 ]
  4. Time to Reach the Target Hb Range in Correction Group Only [ Time Frame: Up to Week 24 ]
  5. Rate of Increase in Hb Level in Correction Group Only [ Time Frame: Up to Week 6 ]

Eligibility Criteria
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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
  • Receiving peritoneal dialysis for more than 4 weeks prior to the screening period. However, receiving hemodialysis is excluded
  • Not expected to start hemodialysis during the study
  • 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
  • Peritonitis within 4 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 (e.g. 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
Contacts and Locations
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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): NCT03402386


Locations
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Japan
Research site
Aichi, Japan
Research site
Chiba, Japan
Research site
Fukuoka, Japan
Research site
Fukushima, Japan
Research site
Gunma, Japan
Research site
Hokkaido, Japan
Research site
Hyogo, Japan
Research site
Ibaraki, Japan
Research site
Kagoshima, Japan
Research site
Kanagawa, Japan
Research site
Kyoto, Japan
Research site
Nagano, Japan
Research site
Nara, Japan
Research site
Okayama, Japan
Research site
Okinawa, Japan
Research site
Shiga, Japan
Research site
Tokyo, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: General Manager Mitsubishi Tanabe Pharma Corporation
  Study Documents (Full-Text)

Documents provided by Mitsubishi Tanabe Pharma Corporation:
Study Protocol  [PDF] December 26, 2017
Statistical Analysis Plan  [PDF] March 26, 2019

More Information
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Publications of Results:

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT03402386    
Other Study ID Numbers: MT-6548-J02
First Posted: January 18, 2018    Key Record Dates
Results First Posted: July 6, 2021
Last Update Posted: August 3, 2021
Last Verified: August 2021

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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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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
 Hematologic Diseases
Urologic Diseases
Renal Insufficiency