Phase 3
Completed N=24
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
Source: ClinicalTrials.gov NCT03461146 ↗
Enrolled (actual)
24
Serious AEs
29.2%
Results posted
May 2021
Primary outcomePrimary: Mean Hb Level of Week 20 and Week 24 — 10.75 g/dL
◆ Published Evidence
Emerging
10citations · ~3 / year
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.
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.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Hb Level of Week 20 and Week 24 |
10.75 | — |
| PRIMARY Hb Level at Each Assessment Time Point |
9.15; 9.25; 9.53; 9.90; 10.33; 10.56 | — |
| PRIMARY Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period |
16.7; 21.7; 36.4; 47.6; 55.0; 63.2 | — |
| PRIMARY Time to Reach the Target Hb Range |
67.2 | — |
| PRIMARY Rate of Increase in Hb Level |
0.05; 0.09 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT03461146) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.