Challenge V Study

JRCT ID: jRCTs051210090

Registered date:22/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: renal anemia
• Date of first enrollment: 22/09/2021
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Vadadustat is orally administered according to the dose adjustment algorithm

Outcome(s)

• Primary Outcome: Hemoglobin level at each point in the treatment period

Secondary Outcome

:Percentage of subjects whose Hb value is within target range (10.0 g/dL or more and less than 12.0g/dL), or less than 10.0 g/dL and 12.0 g/dL or more
:Vadadustat dose
:Hb rise rate (g/dL/week)
:Hematocrit value
:Platelet count
:Red blood cell-related parameters (red blood cell count, reticulocyte count, MCV, MCH, MCHC)
:Hepcidin
:Iron dose
:Erythroferrone

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Aged 20 years or older at the time of obtaining consent (irrespective of sex)
2. Diagnosis of CKD based on evidence-based clinical practice guidelines for CKD 2018 (edited by the Japanese Society of Nephrology) by the time of obtaining consent
3. Receiving hemodialysis or hemodiafiltration 3 times a week for more than 12 weeks prior to the time of obtaining consent, excluding receiving home dialysis or combination of peritoneal dialysis
4. Receiving the same ESA by the same route, at the same intervals, and at the prescribed dose within 8 weeks prior to the time of obtaining consent
5. Mean of the two screening Hb levels closest in the time of obtaining consent (average of the latest 2 times) is 9.5 g/dL or higher and <12.0 g/dL
6. Fluctuation between the two Hb levels closest in the time of obtaining consent during the screening period less than 1.5 g/dL
7. Serum ferritin level of 100ng/mL or higher and transferrin saturation level (TSAT) of 20% or higher before the time of obtaining consent (If the serum ferritin level is less than 100ng/mL or the TSAT is less than 20%, these parameters are measured again. The patients can enter the study after confirmation of serum ferritin level is 100 ng/mL or more and the TSAT is 20% or more.)

Exclude criteria

1. 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) after the time of obtaining consent
2. Active bleeding or recent blood loss within 8 weeks prior to the time of obtaining consent
3. RBC transfusion within 8 weeks prior to the time of obtaining consent
4. Received testosterone enanthate or mepitiostane within 8 weeks prior to the time of obtaining consent
5. Patients who are judged by the principal investigator (or sub-investigators) to require treatment such as salvage treatment or withdrawal of the investigated drug after the start of the investigated drug
6. Patients who are expected to eliminate the need for hemodialysis or hemodiafiltration due to recovery of renal function
7. AST (standard value: 10 to 40 U/L), ALT (standard value: 5 to 45 U/L), or total bilirubin (standard value: 0.2 to 1.2 mg/dL) before the time of obtaining consent >2.5 x upper limit of normal; does not apply to patients with Gilbert's syndrome
8. Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg)
9. Severe heart failure (New York Heart Association Class IV)
10. Cerebrovascular disorder or acute coronary syndrome (hospitalization due to unstable angina or myocardial infarction), requiring hospitalization due to urgent percutaneous coronary intervention or heart failure within 12 weeks prior to the time of obtaining consent
11. Current or past history of malignancy. History of malignancy with no recurrence for the recent 5 years (or no recurrence for the recent 5 years after the last administration of anticancer drugs) is not an exclusion criterion
12. New onset or recurrent event of deep vein thrombosis or pulmonary embolism within 12 weeks prior to the time of obtaining consent
13. Current or history of hemosiderosis or hemochromatosis
14. History of prior organ transplantation or scheduled organ transplant, or prior transplantation of hematopoietic stem cell or bone marrow; does not apply to patients scheduled to be enrolled in the kidney transplant waiting list
15. Patients participating in interventional trials (including clinical trials) other than this study
16. Patient with intolerable for HIF-PH inhibitors
17. Female patients who are pregnant or breast feeding, or are predicted to be pregnant
18. Patients whose folic acid and vitamin B12 are deviated from the minimum value( folic acid:3.6ng/mL and vitamin B12:233pg/mL)
19. Patients who are judged by the doctors to be ineligible for complications or medical history such as cerebral infarction, myocardial infarction, or pulmonary embolism
20. Patients who are judged by the principal investigator (or sub-investigators) to be inappropriate as subjects in this study

Related Information

• Primary Sponsor: Tsuruya Kazuhiko
• Secondary Sponsor: Mitsubishi Tanabe Pharma Corporation