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

Phase 3

Completed

Conditions: Anemia; Non-dialysis Dependent Chronic Kidney Disease

Interventions: Drug: MT-6548
Drug: Darbepoetin alfa

Registration Number: NCT03329196

Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary: For Non-dialysis subjects 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.

For subjects not currently receiving ESAs, evaluate Hb correction and maintenance effect of MT-6548 and for subjects currently receiving ESAs, evaluate Hb conversion and maintenance effect of MT-6548

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 304

Inclusion Criteria

Diagnosis of CKD
eGFR < 60 mL/min/1.73m^2 during the screening period
Not receiving dialysis for 8 weeks prior to the screening period, and not expected to start dialysis during the treatment period
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
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 (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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MT-6548	MT-6548	-
Darbepoetin alfa	Darbepoetin alfa	-

Primary Outcome Measures

Name	Time	Method
Mean Hb Level of Week 20 and Week 24	Up to Week 24

Secondary Outcome Measures

Name	Time	Method
Hb Level at Each Assessment Time Point	Up to Week 52
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period	Up to Week 52
Rate of Increase in Hb Level in Correction Group Only	Up to Week 6
Mean Hb Level of Week 48 and Week 52	Up to Week 52
Time to Reach the Target Hb Range in Correction Group Only	Up to Week 52