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

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

Ueki Yasushi

Shinshu University School of Medicine

Asahi 3-1-1, Matsumoto

yasushi522@shinshu-u.ac.jp

Ueki Yasushi

Shinshu University School of Medicine

Asahi 3-1-1, Matsumoto

+81-263-37-3352

yasushi522@shinshu-u.ac.jp

Recruiting

Dec. 12, 2023

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

1. Aged 20-90 years at the time of obtaining consent.
2. Established LEAD, defined as ABI <0.90 or history of lower extremity peripheral artery revascularization within the pre-treatment observation period.
3. eGFR less than 60ml/min/1.73m2 within the 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. TSAT more than or equal to 20% within the pre-treatment observation period.
6. Folic acid and vitamin B12 levels above the lower limit of normal within 24 weeks before randomization.
7. Provided written consent to participate in the study.

1. Hemodialysis or peritoneal dialysis at the time of randomization, or scheduled within 24 weeks from the time of randomization
2. History of polycystic kidney disease
3. Treated with an ESA within 5 weeks before randomization
4. Red blood cell transfusion within 12 weeks before randomization, or expected to occur during the study period
5. A history of treatment with HIF-PH inhibitors within 12 weeks before randomization
6. Anemia due to conditions other than chronic kidney disease
7. Patients with major bleeding* within 12 weeks before randomization (*major bleeding is defined as BARC 3 bleeding)
8. 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
9. 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
10. Diabetic retinopathy on treatment, or untreated pre-proliferative/proliferative diabetic retinopathy by Davis classification
11. History of acute myocardial infarction, cerebral infarction, deep vein thrombosis, or pulmonary thromboembolism within 1 year before randomization
12. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
13. Any clinically significant infection or evidence of an active underlying infection
14. Any prior functioning organ transplant or a scheduled organ transplantation, or anephric
15. 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 within the pre-treatment observation period
16. Poorly controlled arterial hypertention (defined as SBP >180mmHg) within the pre-treatment observation period
17. Judged by the principal investigator to be inappropriate as a research subject

Both

lower extremities artery disease, renal anemia

Intake of Roxadustat

lower extremities artery disease, renal anemia, chronic kidney disease

Roxadustat

D016491,D000740

C584543

Change in hemoglobin level between baseline and 24 weeks after randomization

Changes 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)

+81-25-368-9343

Dec. 05, 2023

No

none