EUCTR2014-000780-40-ES进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of the Safety and Efficacy of Roxadustat in the Treatment of Anemia in Dialysis Patients - ROCKIES
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,106
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Age > or = 18 years
- •- Receiving or initiating hemodialysis or peritoneal dialysis for treatment of native kidney end-stage renal disease at least 30 days prior to visit 1.
- •- Two central laboratory Hb values during the screening period, obtained at least 7 days apart, must be <12 g/dL in patients currently treated with an erythropoietin analouge or <10 g/dL in patients not currently treated with an erythropoietin analouge. Patients are considered not currently treated if they have not received either Mircera® for at least 8 weeks or any other erythropoietin analouge for at least 4 weeks prior to visit 1.
- •- Ferritin > or = 100 ng/mL at randomization.
- •- Transferrin saturation (TSAT) > or = 20% at randomization.
- •- Serum folate level > or = lower limit of normal (LLN) at randomization.
- •- Serum vitamin B12 level > or = LLN at randomization.
- •- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < or = 3x upper limit of normal (ULN), and total bilirubin < or =1.5 x ULN at randomization.
- •- Body weight 45 to 160 kg.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 700
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 700
排除标准
- •- New York Heart Association Class III or intravenous (IV) congestive heart failure at enrollment - Myocardial infarction, acute coronary syndrome, stroke, seizure or a thrombotic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization. - History of chronic liver disease (e.g., chronic infectious hepatitis, chronic autoimmune liver disease, cirrhosis or fibrosis of the liver). - Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red cell aplasia or other known causes for anemia other than chronic kidney disease (CKD). - Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis). - Diagnosis or suspicion (e.g. complex kidney cyst of Bosniak Category IIF, III or IV) of renal cell carcinoma on renal ultrasound (or other imaging procedure e.g. computerized tomography (CT) scan or magnetic resonance imaging (MRI)) conducted at screening or within 12 weeks prior to randomization. - Uncontrolled hypertension at the time of randomization, (defined as systolic BP > or =180 mmHg or diastolic BP > or =100 mmHg on repeated measurement post-dialysis in hemodialysis patients or at any time in peritoneal dialysis patients), contraindication to epoetin alfa treatment (e.g., pure red cell aplasia, hypersensitivity or know inability to tolerate epoetin alfa). - History of prostate cancer, breast cancer or any other malignancy, except the following: cancers determined to be cured or in remission for > or = 5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ or resected colonic polyps. - Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody. - Chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ankylosing spondylitis, psoriatic arthritis or inflammatory bowel disease that is determined to be principal cause of anemia. - Known hemosiderosis, hemochromatosis or hypercoagulable condition. - Any prior organ transplant with the exception of a renal transplant that was subsequently removed (?explanted?) or scheduled organ transplantation date. - Any red blood cell (RBC) transfusion during the screening period. - Any current condition leading to active significant blood loss. - Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). - History of alcohol or drug abuse within 2 years prior to randomization - Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence. - Pregnant or breastfeeding females. - Known allergy to the investigational product or any of its ingredients.
研究者
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