Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Not Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan

Anemia; Hemodialysis Dependent Chronic Kidney Disease Clinical Trial

Official title:

A Phase III, Open-label Study of MT-6548 in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461146
• Other study ID #: MT-6548-J04
• Status: Completed
• Phase: Phase 3
• Start date: March 5, 2018
• Est. completion date: December 17, 2018

Study information

• Verified date: December 2023
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For hemodialysis subjects not receiving ESAs with anemia associated with chronic kidney disease, evaluate Hb correction and maintenance effect and safety of MT-6548.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 17, 2018
• Est. primary completion date: December 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.
• Not being treated with ESAs or if being treated with ESAs, leave defined interval between last ESAs administration and the first day of the screening period
• Mean of the two screening Hb levels closest in time to the baseline visit is =8.0 g/dL and <10.0 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

Related Conditions & MeSH terms

• Anemia
• Anemia; Hemodialysis Dependent Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• MT-6548
Oral tablet

Locations

Country	Name	City	State
Japan	Research site	Aichi
Japan	Research site	Chiba
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	Nagano
Japan	Research site	Okayama
Japan	Research site	Okinawa
Japan	Research site	Osaka
Japan	Research site	Saitama
Japan	Research site	Shiga
Japan	Research site	Shizuoka
Japan	Research site	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Nangaku M, Kondo K, Takabe S, Ueta K, Tandai T, Kawaguchi Y, Komatsu Y. A phase 3, open-label, single-arm study of vadadustat for anemia in chronic kidney disease for Japanese patients on hemodialysis not receiving erythropoiesis-stimulating agents. Ther — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Hb Level of Week 20 and Week 24		Up to Week 24
Primary	Hb Level at Each Assessment Time Point		Up to Week 24
Primary	Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period		Up to Week 24
Primary	Time to Reach the Target Hb Range		Up to Week 24
Primary	Rate of Increase in Hb Level		Up to Week 6