JPRN-jRCTs031230506招募中Unknown
Renal Anemia Treatment with Roxadustat for Non-dialysis Patients with Lower Extremity Artery Disease: The REFINE trial - The REFINE trial
eki Yasushi0 个研究点目标入组 100 人开始时间: 2023年12月12日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 90age old（—）
- 性别
- All
入选标准
- •1.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.
排除标准
- •1.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
研究者
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