ACTRN12613000504718招募中2 期
A Phase 2, Open Label, Multicentre, Sequential Dose Finding Study to Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Multiple Doses of Polysialylated Erythropoietin [PSA-EPO; PSA-epoetin alfa; ErepoXen (registered trade name)] Administered Subcutaneously in Chronic Kidney Disease (CKD) Subjects Not on Dialysis and Not Receiving Erythropoiesis Stimulating Agents (PSA-EPO-06)
Xenetic Biosciences PLC0 个研究点目标入组 90 人开始时间: 2013年5月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Subjects willing to give the written informed consent,
- •2. Males and females aged >18 years. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to the use of a double method of contraception while in the study and for 45 days after study discontinuation.
- •3. Established chronic kidney disease stage 3 or 4, unlikely to require dialysis for at least 16 weeks,
- •4. Two separate haemoglobin (Hb) values of greater than or equal to 8g/dL and less than or equal to 10 g/dL determined using the provided haemoglobin point of care device, Hemacue(TM) within 14 days and at least 2 days apart prior to first study drug administration,
- •5. Serum ferritin greater than or equal to 100 microgram/L or transferrin saturation of greater than or equal to 20% within 2 weeks prior to study drug administration,
- •6. Serum (or red cell) folate and Vitamin B12 levels > lower limit of normal within 4 weeks prior to study drug administration.
- •7. White blood cell count greater than or equal to 3 x 10*9/L within 4 weeks prior to study drug administration,
- •8. Platelet count greater than or equal to 140 x 10*9/L within 4 weeks prior to study drug administration, and
- •9. Weight greater than or equal to 45 (maximum 140) kg within 4 weeks prior to study drug administration.
排除标准
- •1. Previous exposure to any Erythropoietin Stimulating Agents (ESA) within 10 weeks prior to the planned administration of the study drug (PSA-EPO-06)
- •2. Red blood cell transfusion within 12 weeks prior to study drug administration
- •3. More than one dose of intravenous iron within 2 weeks prior to Screening
- •4. Life expectancy <12 months,
- •5. Past history of intolerance to ESA therapy,
- •6. Known intolerance to parenteral iron therapy,
- •7. High likelihood of early withdrawal or interruption of the study due to any medical or social factor,
- •8. C-reactive protein (CRP) >30 mg/L within 4 weeks prior to study drug administration,
- •9. Immunosuppressive therapy within 12 weeks prior to the planned administration of the study drug,
- •10. Grand mal seizure within 6 months prior to the planned study drug administration,
- •11. Uncontrolled arterial hypertension (systolic pressure >180 mm Hg, diastolic pressure > 105 mm Hg) within 6 weeks prior to the planned administration of the study drug,
- •12. Chronic congestive heart failure (NYHA Class III-IV),
- •13. Severe hyperparathyroidism (defined as >10 times upper limit of normal or >150 pmol/L),
- •14. Major surgery within 12 weeks prior to the planned administration of the study drug (subjects due to dialysis access creation can be enrolled),
- •15. Systemic blood diseases (sickle cell disease, myelodysplastic syndrome, myeloma, and haemolytic anaemia),
- •16. Systemic inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.),
- •17. Acute inflammatory disease or infection requiring antibiotics during the screening period,
- •18. Positive for Hepatitis B, C, HIV or syphilis,
- •19. Malignant disease within the past 5 years, or requiring therapy at the time of subject enrolment and in the course of the study (except for non melanoma skin cancer which is not an exclusion criterion),
- •20. Hepatic enzyme (ALT and AST) levels exceeding twice the upper limit of normal,
- •21. Pregnancy or breastfeeding,
- •22. Participation in any other investigational drug study within 4 weeks prior to the planned administration of the drug,
- •23. Prior haemodialysis or peritoneal dialysis treatment
研究者
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