CTIS2023-503634-50-00进行中（未招募）1 期
A Phase III, Randomized, Investigator-Blinded, Active-Controlled Study of Efficacy and Safety of Efepoetin Alfa for Treatment of Anemia in Patients with Chronic Kidney Disease on Dialysis - GX-E4-CKD-002
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 429
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Adult males and females = 18 years old., Serum total vitamin B12 concentrations =LLN at screening., Patient (or patient’s legally acceptable representative) has voluntarily signed and dated an informed consent form (ICF) approved by an Ethics Committee (EC) or institutional review board (IRB) after the nature of the study has been explained and the patient has had the opportunity to ask questions, Patient with stage 4 and 5 CKD defined by estimated GFR (eGFR, =29 mL/min/1.73m2) on adequate HD for a minimum of 12 weeks prior to Day 1. *CKD staging will be based on the five-stage system for classification of CKD based on KDIGO guidelines., Hemodialysis patients with single-pool Kt/V = 1.2 or urea reduction ratio = 65%., Patients must be on stable doses of IV injections of ESA (including biosimilars) for at least 6 weeks prior to Day 1. Minimum ESA dose; ? Epoetin alfa, epoetin beta, and epoetin kappa: =1,500 U/week ? Darbepoetin alfa: =20 µg/week ?Mircera®: =30 µg/2 weeks, Mean of the 2 most recent local laboratory Hb screening values obtained at least 6 days apart must be 9.0 g/dL to 12.0 g/dL, inclusive, with a difference of =1.5 g/dL between the highest and the lowest value., Patients with serum ferritin =100 ng/mL at screening., Patients with transferrin saturation (TSAT) =20% at screening., Serum folate concentrations =lower limit of normal (LLN) at screening.
排除标准
- •Active acute or chronic infection, or uncontrolled or symptomatic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease), or a C-reactive protein level 40> mg/L (high sensitive C-reactive protein level > 10 mg/L)., Any of the following laboratory abnormalities at screening visit; • Alanine transaminase (ALT) >3 x upper limit of normal (ULN) • Aspartate aminotransferase (AST) >3 x ULN • Total bilirubin >1.5 x ULN, Chronic congestive heart failure (New York Heart Association class III or IV)., 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., High risk for early withdrawal or interruption of the study (due to myocardial infarction, severe or unstable coronary artery disease, stroke, or severe liver disease) within the 12 weeks before Screening or during Screening., Uncontrolled hypertension defined as a sitting systolic blood pressure =170 mmHg and/or diastolic blood pressure =100 mmHg (measure BP in both arms, then the arm that gives the higher reading for subsequent readings)., History of active malignancy except for cancers determined to be cured or in remission for =5 years, curatively resected basal cell or squamous cell skin cancers, or in situ cancer at any site., Patients with a history of overt gastrointestinal bleeding or any other bleeding episode associated with a fall in Hb of =1 g/dL within the last 8 weeks prior to Screening., Any medical condition (patients weighing over 150 kg) that, in the opinion of the Investigator, may pose a safety risk to a patient in this study, may confound efficacy or safety assessment, or may interfere with study participation., Any prior functioning organ transplant or a scheduled organ transplantation, or anephric state (one or both kidneys)., Planned elective surgery that could lead to significant blood loss during the study period., Received a blood transfusion (including RBC transfusion) within the 12 weeks prior to Screening, or blood transfusion is anticipated during the study period (excluding temporary blood transfusion given in case of blood loss due to accident or surgery)., Hypoalbuminemia (Serum albumin <2.5 g/dL) at Screening Visit., Androgen, deferoxamine, deferiprone, or deferasirox therapy within 12 weeks prior to Day 1., Life expectancy of <12 months., Cognitive or psychiatric condition rendering the patient unable to be cooperative with and complete study requirements., Hypersensitivity to any one of the investigational drugs or its excipients., Patients with very limited functional capacity for which a target Hb value of 12 g/dL may have a lower benefit/risk ratio., Immunosuppressive therapy (tacrolimus/cyclosporine, and other than corticosteroids for a chronic condition) within 12 weeks prior to Day 1., By history or current clinical evidence, patients with active acute hepatitis B virus (HBV) or hepatitis C virus (HCV) infection should be excluded. Routine screening for HBV, HCV, and human immunodeficiency virus (HIV) infection is not required in this protocol. Chronic HBV/HCV infection with liver function tests (LFT) >3 times of normal are excluded. Known HIV positive patients are excluded., History of alcohol or drug abuse withi
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