NCT00628264终止2 期
Safety, Tolerability and Pharmacodynamics of AP214 Acetate in Patients Undergoing Cardiac Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- To assess the safety and tolerability of AP214 administered as three 10-minute bolus infusions, in patients undergoing cardiac surgery that are at increased risk of AKI (descriptive analysis of AEs and SAEs from Day 0-14).
研究概览
简要总结
The purpose of the present research study is to investigate for the first time, the safety and tolerability of infusion doses of AP214 in subjects having heart surgery such as coronary bypass graft and/or valve repair or replacement surgery. AP214, the investigational drug, is being developed to potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has signed the trial specific informed consent form.
- •Patients ≥ 18 years old, male or female, not of childbearing potential (postmenopausal or permanently sterilized e.g., tubal occlusion, hysterectomy, bilateral salpingectomy), regardless of ethnicity.
- •Patients undergoing CABG, valve(s), CABG/valve and/or aortic root or ascending aortic aneurysm repair surgery.
- •Cleveland Clinic Renal Score ≥ 2 (higher than average risk for AKI).
- •EF ≥ 30%, evaluated within 2 months prior to screening visit.
排除标准
- •Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
- •Circulatory arrest in connection with aortic root or ascending aortic aneurysm repair surgery.
- •Confirmed or suspected endocarditis.
- •Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
- •Receiving Aprotinin during the trial, from Screening to Day
- •Having undergone cardiovascular catheterization ≤ 48 hours prior to scheduled surgery.
- •Active peptic ulcer disease and gastritis.
- •Hemoccult positive stools, hematological, bleeding, and coagulation disorders.
- •Receiving dopamine at renal doses (2-4 mcg/kg/min), from Screening to Day
- •S-Creatinine greater than 2.1 mg/dl.
- •Known or suspected hypersensitivity to the investigational medicinal product.
- •Known or suspected hypersensitivity to ondansetron or other selective 5-hydroxytryptamine 3 (5-HT3) receptor antagonists.
- •Current participation in any other interventional clinical trial.
- •Previously dosed with AP
- •Use of investigational medicinal products within the previous 6 months.
- •Body weight above 140 kg.
- •History of any organ transplant.
- •Women who are of childbearing potential, pregnant or breast-feeding.
- •Current abuse of alcohol or substance, according to the investigator's medical judgment
- •Has a mental incapacity or language barriers precluding adequate understanding of trial procedures.
- •Is considered by the Investigator unsuitable to participate in the trial for any other reason for instance due to a significant serious underlying condition
研究组 & 干预措施
AP214
Experimental
干预措施: AP214 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety and tolerability of AP214 administered as three 10-minute bolus infusions, in patients undergoing cardiac surgery that are at increased risk of AKI (descriptive analysis of AEs and SAEs from Day 0-14).
时间窗: From day 0-14
To assess the impact of AP214 on cardiac surgery induced systemic inflammatory response syndrome determined by the post-operative peak plasma concentrations of IL-6 and IL-10 from 0-24 hours
时间窗: 0-24 hours
次要结局
- To assess the safety and tolerability of AP214 at an organ level as well as in terms of the overall mortality (heart, CNS, lung, wound, mortality)(Day 0-90)
- To assess the impact of AP214 on cardiac surgery induced systemic inflammatory response syndrome (post-operative peak plasma concentrations of TNF-α and IL-8 and AUC for TNF-α, IL-6, IL-8 and IL-10).(0-24 hours)
- To assess the impact of AP214 for renal protection as measured by the development of post-surgical acute kidney injury (AKIN score)(Day 0-14)
- To assess the impact of AP214 on the development of post-surgical left ventricular dysfunction (determined by changes in left ventricular function from pre to post coronary bypass by transesophageal echocardiography(0-24 hours)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Pharmacokinetics of AP214 Acetate in Patients Undergoing Cardiac SurgeryCardiac SurgeryCoronary Artery Bypass GraftingValve SurgeryAortic Root or Ascending Aortic Aneurysm Repair SurgeryNCT00903604Action Pharma A/S42
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1356 BS Administered to Healthy Male SubjectsHealthyNCT02173665Boehringer Ingelheim64
已完成
1 期
Single Rising Dose Study of BI 135585 XX in Health Asian Male Volunteers.HealthyNCT01291732Boehringer Ingelheim48
暂停
1 期
APL-102 Capsule in Patients With Advanced Solid TumorsAdvanced Solid TumorNCT05055518Apollomics Inc.30
Unknown
1 期
A Safety，Tolerability and Pharmacokinetics Clinical Trial of JX11502MA CapsuleSchizophreniaNCT05233657Zhejiang Jingxin Pharmaceutical Co., Ltd.58