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

NCT ID: NCT03461146

Last Updated: 2023-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-05
• Study Completion Date: 2018-12-17

Brief 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.

Conditions

Anemia; Hemodialysis Dependent Chronic Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MT-6548

Group Type: EXPERIMENTAL

MT-6548

Intervention Type: DRUG

Oral tablet

Interventions

MT-6548

Oral tablet

Intervention Type: DRUG

Other Intervention Names

vadadustat; AKB-6548

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.
• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

General Manager

Role: STUDY_DIRECTOR

Mitsubishi Tanabe Pharma Corporation

Locations

Research site

Aichi, , Japan

Research site

Chiba, , Japan

Research site

Fukushima, , Japan

Research site

Gunma, , Japan

Research site

Hokkaido, , Japan

Research site

Hyōgo, , 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, , Japan

Countries

Japan

References

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 Apher Dial. 2022 Feb;26(1):45-54. doi: 10.1111/1744-9987.13699. Epub 2021 Jun 28.

Reference Type: RESULT

PMID: 34115437 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MT-6548-J04

Identifier Type: -

Identifier Source: org_study_id