CTRI/2015/12/006461进行中（未招募）3 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
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,425
- 试验地点
- 15
- 主要终点
- Major adverse cardiovascular (CV) events (MACE): Time to first occurrence of death from any cause, non-fatal myocardial infarction or non-fatal stroke.
研究概览
简要总结
This is a Phase 3, multicenter, randomized, open-label, active-controlled study to evaluate the safety and efficacy of roxadustat compared to epoetin alfa for the treatment of anemia in dialysis patients. Patients on hemodialysis (HD) or peritoneal dialysis (PD) who have been treated with an erythropoietin analogue or have an indication for treatment with an erythropoietin analogue will be evaluated for eligibility and randomized at a 1:1 ratio to treatment with roxadustat (with discontinuation of prior erythropoietin analogue therapy) or to an active-control group treated with epoetin alfa
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Receiving or initiating hemodialysis or peritoneal dialysis for treatment of native kidney end-stage renal disease at least 30 days prior to visit
- •Two central laboratory hemoglobin values during the screening period, obtained at least 7 days apart, must be <12 g/dL in patients currently treated with an erythropoietin analogue or <10 g/dL in patients not currently treated with an erythropoietin analogue.
- •Patients are considered not currently treated if they have not received either Mircera® for at least 8 weeks or any other erythropoietin analogue for at least 4 weeks prior to visit
- •Ferritin ≥100 ng/mL at randomization.
- •Transferrin saturation (TSAT) ≥20% at randomization.
- •Serum folate level ≥ lower limit of normal (LLN) at randomization.
- •Serum vitamin B12 level ≥LLN at randomization.
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3x upper limit of normal (ULN), and total bilirubin ≤1.5 x ULN at randomization.
- •Body weight 45 to 160 kg.
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 II F, 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 ≥180 mmHg or diastolic BP ≥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 ≥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 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.
结局指标
主要结局
Major adverse cardiovascular (CV) events (MACE): Time to first occurrence of death from any cause, non-fatal myocardial infarction or non-fatal stroke.
时间窗: Major adverse cardiovascular (CV) events (MACE): Time to first occurrence of death from any cause, non-fatal myocardial infarction or non-fatal stroke. | The number from randomization to the first occurrence of any of the components of the primary composite endpoint
The number from randomization to the first occurrence of any of the components of the primary composite endpoint
时间窗: Major adverse cardiovascular (CV) events (MACE): Time to first occurrence of death from any cause, non-fatal myocardial infarction or non-fatal stroke. | The number from randomization to the first occurrence of any of the components of the primary composite endpoint
次要结局
- Mean change in hemoglobin (Hb) from baseline to the end of treatment period (event-driven, anticipate 1-2 years).(Baseline to end of study (event-driven, anticipate 1-2 years))
- Mean value of all Hb measurements(From week 28 until the end of study will be used.)
- Proportion of total time of Hb measurements within the interval of 11±1 g/dL(From week 28 until end of study (event-driven, anticipate 1-2 years))
- Proportion of total time of Hb values within the interval 11±1 g/dL(From week 28 until end of treatment visit.)
- Time to first occurrence of all-cause mortality, non-fatal myocardial infarction (MI) or non-fatal stroke, heart failure requiring hospitalization or unstable angina leading to hospitalization(The number from randomization to the first occurrence of any of the components of the primary composite endpoints.)
- Time to first occurrence of death from any cause, MI, stroke, heart failure requiring hospitalization, unstable angina leading to hospitalization, vascular access thrombosis, deep vein thrombosis, pulmonary embolism or hypertensive emergency.(From randomization (week 0) to end of study (event-driven, anticipate 1-2 years).)
- Time to first rescue therapy (composite of erythropoietin analogue therapy [for roxadustat-allocated patients only] or RBC transfusion)(From randomization (week 0) to end of study (event-driven, anticipate 1-2 years).)
- Changes in self-reported health status as measured by the EuroQol Health Utility Index 5-dimensional-5-level (EQ-5D-5L) during roxadustat or epoetin alfa treatment.(At baseline, week 12, 28 and 52)
- Adverse events (AEs), serious adverse events (SAEs) Changes in vital signs, electrocardiogram (ECG) and laboratory values. Measured at randomization (week 0) to end of study (event-driven, anticipate 1-2 years)(From the first screening visit to the end of the study (event-driven, anticipate 1-2 years)
研究者
研究点 (15)
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