Intervention: Vadadustat
Trial phase: Phase 3
ATC code: B03XA08
SMILES: O=C(O)CNC(=O)c1ncc(-c2cccc(Cl)c2)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of CKD
Receiving peritoneal dialysis for more than 4 weeks prior to the screening period. However, receiving hemodialysis is excluded
Not expected to start hemodialysis during the study
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
Peritonitis within 4 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 (e.g. 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