jRCTs031230506招募中不适用
Renal Anemia Treatment with Roxadustat for Non-dialysis Patients with Lower Extremity Artery Disease: The REFINE trial (The REFINE trial)
未提供0 个研究点目标入组 100 人开始时间: 2024年4月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 90age old under（—）
- 性别
- All
入选标准
- •Aged 20-90 years at the time of obtaining consent.
- •Established LEAD, defined as ABI <0.90 or history of lower extremity peripheral artery revascularization within the pre-treatment observation period.
- •eGFR less than 60ml/min/1.73m2 within the pre-treatment observation period.
- •Hemoglobin level of more than or equal to 7.5 and less than 11.0 g/dl at the time of randomization.
- •TSAT more than or equal to 20% within the pre-treatment observation period.
- •Folic acid and vitamin B12 levels above the lower limit of normal within 24 weeks before randomization.
- •Provided written consent to participate in the study.
排除标准
- •Hemodialysis or peritoneal dialysis at the time of randomization, or scheduled within 24 weeks from the time of randomization
- •History of polycystic kidney disease
- •Treated with an ESA within 5 weeks before randomization
- •Red blood cell transfusion within 12 weeks before randomization, or expected to occur during the study period
- •A history of treatment with HIF-PH inhibitors within 12 weeks before randomization
- •Anemia due to conditions other than chronic kidney disease
- •Patients with major bleeding* within 12 weeks before randomization (*major bleeding is defined as BARC 3 bleeding)
- •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
- •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
- •Diabetic retinopathy on treatment, or untreated pre-proliferative/proliferative diabetic retinopathy by Davis classification
- •History of acute myocardial infarction, cerebral infarction, deep vein thrombosis, or pulmonary thromboembolism within 1 year before randomization
- •Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
- •Any clinically significant infection or evidence of an active underlying infection
- •Any prior functioning organ transplant or a scheduled organ transplantation, or anephric
- •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
- •Poorly controlled arterial hypertention (defined as SBP >180mmHg) within the pre-treatment observation period
- •Judged by the principal investigator to be inappropriate as a research subject
结局指标
主要结局
-
Change in hemoglobin level between baseline and 24 weeks after randomization
次要结局
未报告次要终点
研究者
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