A Phase 3, Multicenter, Randomized, Open-Label Active-Controlled Study of the Efficacy and Safety of FG-4592 in the Treatment of Anemia in Incident-dialysis Patients

FIBROGEN, INC,0 个研究点目标入组 6 人开始时间: 2014年12月11日最近更新: 2023年9月4日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 6

研究概览入排标准研究者记录与标识符相似试验

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 100（—）

入选标准

•1.Age ≥18 years.
•2.Subject has been informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines.
•3.Receiving hemodialysis or peritoneal dialysis for native kidney end-stage renal disease (ESRD) for a minimum of 2 weeks and a maximum of 4 months, prior to randomization.
•4.Hemodialysis access consisting of an arteriovenous (AV) fistula, AV graft, or tunnelled (permanent) catheter;
•Peritoneal dialysis catheter in use.
•5.Mean of the three most recent Hb values during the Screening Period, obtained at least 4 days apart, must be ≤10.0 g/dL, with a difference of ≤1.3 g/dL between the highest and the lowest values. The last Hb value must be drawn within 10 days prior to randomization.
•6.Ferritin ≥50 ng/mL.
•7.TSAT ≥10%.
•8.Serum folate level, performed within 8 weeks prior to randomization ≥ lower limit of normal (LLN).
•9.Serum vitamin B12 level, performed within 8 weeks prior to randomization ≥ LLN.
•10.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3x upper limit of normal (ULN), and total bilirubin (Tbili) < 1.5 x ULN.
•11.Body weight 45 to 160 kg (dry weight).

排除标准

•1.Any ESA treatment within 12 weeks prior to randomization.
•2.More than one dose of IV iron within 4 weeks prior to randomization.
•3.RBC transfusion within 8 weeks prior to randomization.
•4.Active, clinically significant infection that could be manifested by white blood cell (WBC) count >ULN, and/or fever, in conjunction with clinical signs or symptoms of infection.
•5.History of chronic liver disease (e.g. chronic infectious hepatitis, chronic auto-immune liver disease, cirrhosis, or fibrosis of the liver).
•6.New York Heart Association Class III or IV congestive heart failure.
•7.Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization.
•8.Uncontrolled hypertension, in the opinion of the investigator, (e.g. that requires change in anti-hypertensive medication) within 2 weeks prior to randomization.
•9.Renal ultrasound performed within 12 weeks prior to randomization indicative of a diagnosis or suspicion (e.g., complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma.
•10.History of malignancy, except for 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.
•11.Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab).
•12.Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease) even if it is currently in remission.
•13.Known, untreated proliferative diabetic retinopathy, diabetic macular edema, macular degeneration, or retinal vein occlusion.
•14.Known history of myelodysplastic syndrome or multiple myeloma.
•15.Known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than chronic kidney disease (CKD).
•16.Known hemosiderosis, hemochromatosis, coagulation disorder, or a hypercoagulable condition.
•17.Any prior organ transplant (that has not been explanted), or a scheduled organ transplantation.
•18.Anticipated elective surgery, except for vascular access surgery or dialysis catheter placement, that is expected to lead to significant blood loss, or anticipated elective coronary revascularization.
•19.Known, active or chronic gastrointestinal bleeding.
•20.Any prior treatment with FG-4592 or a HIF prolyl hydroxylases (HIF-PHI).
•21.Use of iron-chelating agents within 4 weeks prior to randomization.
•22.Known hypersensitivity reaction to any ESA.
•23.Use of an investigational drug or treatment, participation in an investigational study, or presence of an expected carryover effect of an investigational treatment, within 4 weeks prior to randomization.
•24.Anticipated use of dapsone in any dose amount or chronic use of acetaminophen or paracetamol >2.0 g/day during the treatment or follow-up periods of the study.
•25.History of alcohol or drug abuse within 2 years prior to randomization.
•26.Females of childbearing potential, unless using contraception as detailed in the protocol; male subjects with sexual partners of childbearing potential who are not on birth control unless the male subj

研究者

发起方

FIBROGEN, INC,

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