EUCTR2013-003585-14-DE进行中（未招募）1 期
Safety, PK/PD and efficacy of NOX-H94 in dialysis patients with ESA-hyporesponsive anaemia: A randomized, double blind, placebo controlled parallel group study with a single blind cross-over group - SNOXH94C301
OXXON Pharma AG0 个研究点目标入组 32 人开始时间: 2014年11月4日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent
- •2. Male or female of non-childbearing potential
- •3. Age 18 to 85 years
- •4. End stage renal disease treated with maintenance haemodialysis since =3 months, 3 times weekly
- •5. Anaemia : Hb 7 to 11 g/dL
- •6. Functional iron deficiency: Transferrin saturation <30%,
- •Ferritin =300 ng/mL.
- •7. ESA hyporesponsiveness with erythropoietin dose =12,000 IU/ week stable for =4 weeks
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Inability to personally provide written informed consent or to under-stand and collaborate throughout the study.
- •2. Inability or unwillingness to comply with study restrictions.
- •3. Participation in any clinical research study evaluating an investigational drug or therapy within 30 days from screening visit or prior enrolment in this study.
- •4. Pregnancy or lactation.
- •5. Treatment with darbepoetin or methoxy-polyethylenglycol-epoetin
- •6. Uncontrolled cardiovascular disease, unstable peripheral arterial or cerebrovascular disease, uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg).
- •7. Congestive heart failure: New York Heart Association Class III or IV.
- •8. Unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty/stents, or coronary artery bypass grafting <3 months prior screening.
- •9. Any other medical conditions requiring a change in treatment within 4 weeks prior to screening or making study participation unadvisable (at the discretion of the investigator).
- •10. History of clinically relevant haemolysis and/or blood loss.
- •11. AST, ALT, or bilirubin =2.0 times the upper limit of normal.
- •12. Known bone marrow fibrosis.
- •13. Treatment with i.v. iron <4 weeks prior to screening or during the screening period or change in erythropoietin dose during last month.
- •14. Any acute or chronic infection, viral or bacterial within 4 weeks prior to screening or during the screening period that, according to investigator's judgement, is considered as systemic infection.
研究者
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