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

Phase 3

Completed

• Conditions: Anemia; Hemodialysis Dependent Chronic Kidney Disease
• Interventions: Drug: MT-6548

• Registration Number: NCT03461146
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-05
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-09
• Primary Completion: 2018-12-03
• Study Completion: 2018-12-17
• Results First Submitted: 2021-03-15
• Results First Submitted QC: 2021-04-26
• Results First Posted: 2021-05-07
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MT-6548	MT-6548	-

Primary Outcome Measures

Name	Time	Method
Mean Hb Level of Week 20 and Week 24	Up to Week 24
Hb Level at Each Assessment Time Point	Up to Week 24
Time to Reach the Target Hb Range	Up to Week 24
Rate of Increase in Hb Level	Up to Week 6
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period	Up to Week 24

Trial Locations

Locations (1)

Research site; 🇯🇵 Yamagata, Japan