KCT0001691招募中未知
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 (FGCL-4592-063)
ovotech Asia Korea0 个研究点目标入组 750 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18 至 o Limit（—）
- 性别
- All
入选标准
- •1. Age = 18 years.
- •2. Receiving hemodialysis or peritoneal dialysis for end-stage renal disease for a minimum of 2 weeks and a maximum of 4 months, prior to study participation.
- •3. Study participant has permanent dialysis access in place.
- •4. No iron deficiency.
- •5. No folate or Vitamin B12 deficiency.
- •6. No abnormal liver tests.
- •7. Body weight up to 160 kg (HD(hemodialysis): dry weight).
- •Note: Blood tests will be conducted to determine whether or not study participant has anemia, and meets all eligibility criteria.
排除标准
- •1. Any erythropoieisis-stimulating agent treatment within 12 weeks prior to participating in the study.
- •2. Intravenous iron within 10 days prior to participating in the study.
- •3. Red blood cell transfusion within 8 weeks prior to participating in the study.
- •4. Active infection.
- •5. Chronic liver disease (e.g., chronic infectious hepatitis, chronic auto-immune liver disease, cirrhosis, or fibrosis of the liver).
- •6. Congestive heart failure.
- •7. Heart attack, stroke, or blood-clots within a major vessel within 12 weeks prior to participating in the study.
- •8. Uncontrolled high blood pressure within 2 weeks prior to participating in the study.
- •9. Renal ultrasound performed within 12 weeks prior to participating in the study suspicious of renal cancer.
- •10. Active cancer.
- •11. Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- •12. Chronic inflammatory disease that could cause anemia.
- •13. Known and untreated damage to the retina from diabetes.
- •14. Known history of blood-related diseases causing anemia, or blood-related cancer.
- •15. Known inherited disease such as thalassemia or sickle cell anemia or other known causes for anemia other than chronic kidney disease.
- •16. Known clotting disorders and iron storage disorders.
- •17. Any prior organ transplant (that has not been explanted), or a scheduled organ transplantation.
- •18. Anticipated surgery that is expected to cause blood loss.
- •19. Known gastrointestinal bleeding.
- •20. Any prior treatment with FG-4592 (roxadustat) or a hypoxia-inducible factor prolyl hydroxylase inhibitor.
- •21. Use of iron-binding medications within 4 weeks prior to participating in the study.
- •22. Known allergies to any erythropoieisis-stimulating agent.
- •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 participating in the study.
- •24. Anticipated use of dapsone or androgens at any dose amount or chronic use of acetaminophen or paracetamol >2.0 g/day during the study.
- •25. History of alcohol or drug abuse within 2 years prior to participating in the study.
- •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 subject agrees to use contraception.
- •27. Pregnant or breastfeeding women.
- •28. Any medical condition, that in the opinion of the study doctor, may pose a safety risk to the patient, may confound efficacy or safety assessment, or may interfere with study participation
研究者
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