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Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan

Primary Purpose

Anemia; Hemodialysis Dependent Chronic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
MT-6548
Darbepoetin alfa
MT-6548-matching placebo
Darbepoetin alfa-matching placebo
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia; Hemodialysis Dependent Chronic Kidney Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • 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 is ≥9.5 g/dL and ≤12.0 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

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) 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
  • 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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MT-6548

Darbepoetin alfa

Arm Description

Outcomes

Primary Outcome Measures

Mean Hb Level of Week 20 and Week 24

Secondary Outcome Measures

Mean Hb Level of Week 48 and Week 52
Hb Level at Each Assessment Time Point
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period

Full Information

First Posted
February 14, 2018
Last Updated
August 2, 2021
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03439137
Brief Title
Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan
Official Title
A Phase III, Double Blind, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 14, 2018 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
July 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

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

5. Study Description

Brief Summary
For hemodialysis subjects currently receiving ESAs 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia; Hemodialysis Dependent Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
323 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT-6548
Arm Type
Experimental
Arm Title
Darbepoetin alfa
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
MT-6548
Other Intervention Name(s)
vadadustat, AKB-6548
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Darbepoetin alfa
Intervention Description
Intravenous administration
Intervention Type
Drug
Intervention Name(s)
MT-6548-matching placebo
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Darbepoetin alfa-matching placebo
Intervention Description
Intravenous administration
Primary Outcome Measure Information:
Title
Mean Hb Level of Week 20 and Week 24
Time Frame
Up to Week 24
Secondary Outcome Measure Information:
Title
Mean Hb Level of Week 48 and Week 52
Time Frame
Up to Week 52
Title
Hb Level at Each Assessment Time Point
Time Frame
Up to Week 52
Title
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Time Frame
Up to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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 is ≥9.5 g/dL and ≤12.0 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 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) 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
General Manager
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Research site
City
Aichi
Country
Japan
Facility Name
Research site
City
Chiba
Country
Japan
Facility Name
Research site
City
Fukui
Country
Japan
Facility Name
Research site
City
Fukuoka
Country
Japan
Facility Name
Research site
City
Fukushima
Country
Japan
Facility Name
Research site
City
Gunma
Country
Japan
Facility Name
Research site
City
Hiroshima
Country
Japan
Facility Name
Research site
City
Hokkaido
Country
Japan
Facility Name
Research site
City
Hyogo
Country
Japan
Facility Name
Research site
City
Ibaraki
Country
Japan
Facility Name
Research site
City
Kagawa
Country
Japan
Facility Name
Research site
City
Kagoshima
Country
Japan
Facility Name
Research site
City
Kanagawa
Country
Japan
Facility Name
Research site
City
Kumamoto
Country
Japan
Facility Name
Research site
City
Kyoto
Country
Japan
Facility Name
Research site
City
Miyagi
Country
Japan
Facility Name
Research site
City
Nagano
Country
Japan
Facility Name
Research site
City
Nagasaki
Country
Japan
Facility Name
Research site
City
Oita
Country
Japan
Facility Name
Research site
City
Okayama
Country
Japan
Facility Name
Research site
City
Okinawa
Country
Japan
Facility Name
Research site
City
Osaka
Country
Japan
Facility Name
Research site
City
Saitama
Country
Japan
Facility Name
Research site
City
Shiga
Country
Japan
Facility Name
Research site
City
Shizuoka
Country
Japan
Facility Name
Research site
City
Tokushma
Country
Japan
Facility Name
Research site
City
Tokyo
Country
Japan
Facility Name
Research site
City
Yamagata
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33650630
Citation
Nangaku M, Kondo K, Ueta K, Kokado Y, Kaneko G, Matsuda H, Kawaguchi Y, Komatsu Y. Efficacy and safety of vadadustat compared with darbepoetin alfa in Japanese anemic patients on hemodialysis: a Phase 3, multicenter, randomized, double-blind study. Nephrol Dial Transplant. 2021 Aug 27;36(9):1731-1741. doi: 10.1093/ndt/gfab055.
Results Reference
result
PubMed Identifier
36005278
Citation
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.
Results Reference
derived

Learn more about this trial

Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan

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