NIPH Clinical Trials Search

JRCT ID: jRCTs031230506

Registered date:12/12/2023

Renal Anemia Treatment with Roxadustat for Non-dialysis Patients with Lower Extremity Artery Disease: The REFINE trial

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedlower extremities artery disease, renal anemia
Date of first enrollment12/12/2023
Target sample size100
Countries of recruitment
Study typeInterventional
Intervention(s)Intake of Roxadustat


Primary OutcomeChange in hemoglobin level between baseline and 24 weeks after randomization
Secondary OutcomeChanges in laboratory tests , ABI, duplex ultrasound (PSV, PSVR), QOL score (EQ-5D-5L, SF-36v2, PHQ-9, Vascu-QOL, WIQ), 6 minutes walking distance between baseline and 24 weeks. Clinical outcomes at 24 weeks (all-cause death, cardiovascular death, non-cardiovascular death, myocardial infarction, unplanned coronary revascularization, unplanned peripheral revascularization, stroke, admission due to heart failure, bleeding, lower limb amputation, hemodialysis)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 90age old
Include criteria1.Aged 20-90 years at the time of randomization. 2.Established LEAD, defined as ABI <0.90 or history of lower extremity peripheral artery revascularization within pre-treatment observation period. 3.eGFR less than 60ml/min/1.73m2 within pre-treatment observation period. 4.Hemoglobin level of more than or equal to 7.5 and less than 11.0 g/dl at the time of randomization. 5.Ferritin level of more than or equal to 100 ng/ml and TSAT more than or equal to 20% at the time of randomization. 6.Folic acid and vitamin B12 levels within the normal range at the time of randomization. 7.Provided written consent to participate in the study.
Exclude criteria1.Hemodialysis or peritoneal dialysis at the time of randomization, or scheduled within 6 months from the time of randomization 2.History of major amputation (defined as amputation above the ankle) 3.History of polycystic kidney disease 4.Treated with an ESA within 5 weeks before randomization 5.Red blood cell transfusion within 12 weeks before randomization, or expected to occur during the study period 6.A history of treatment with HIF-PH inhibitors 7.Anemia due to conditions other than chronic kidney disease 8.Patients with major bleeding* within 3 months before randomization (*major bleeding is defined as BARC 3 bleeding) 9.Known history of myelodysplastic syndrome, multiple myeloma, hereditary hematologic disease such as thalassemia, sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis, hemochromatosis, known coagulation disorder, or hypercoagulable condition 10.Presence of a malignant tumor noted within 2 years before randomization, except for treated basal cell carcinoma of the skin, squamous cell carcinoma cured by resection, and intraepithelial carcinoma of the cervix 11.History of diabetic retinopathy 12.History of acute myocardial infarction, cerebral infarction, deep vein thrombosis, or pulmonary thromboembolism within 1 year before randomization 13.History of pulmonary hypertension 14.Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab) 15.Any clinically significant infection or evidence of an active underlying infection 16.Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis) 17.Any prior functioning organ transplant or a scheduled organ transplantation, or anephric 18.AST or ALT >3 times the upper limit of normal, total bilirubin >2 times the upper limit of normal, or Child-Pugh B or C at screening 19.Poorly controlled arterial hypertention (defined as SBP >180mmHg) at screening 20.Judged by the principal investigator to be inappropriate as a research subject

Related Information


Public contact
Name Yoshiteru Okina
Address Asahi 3-1-1, Matsumoto Nagano Japan 390-8621
Telephone +81-263-37-3352
Affiliation Shinshu University School of Medicine
Scientific contact
Name Yasushi Ueki
Address Asahi 3-1-1, Matsumoto Nagano Japan 390-8621
Telephone +81-263-37-3486
Affiliation Shinshu University School of Medicine