A Prospective, Multicenter, Single-blind, Placebo-controlled, Safety and Tolerability Study of the Effects of Carbon Monoxide for Inhalation in Patients Receiving Kidney Transplants.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Mallinckrodt
- 试验地点
- 3
- 主要终点
- Evaluate the safety and tolerability of three carbon monoxide dose levels when administered as an inhaled gas for 1 hour in patients receiving kidney transplants
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of two carbon monoxide doses when administered as an inhaled gas for 1 hour in patients receiving kidney transplants.
详细描述
The mechanisms by which carbon monoxide exerts its effects in preventing damage of the graft appear to vary among the models and organs with the common theme of carbon monoxide acting as a potent anti-inflammatory molecule. Carbon monoxide affects several intracellular signaling pathways. In addition, carbon monoxide generates increased levels of anti-inflammatory molecules.
Evaluate the safety and tolerability of three carbon monoxide dose levels consisting of a single 0.7 mg/kg dose and a single 2.0 mg/kg dose when administered post-operatively and a single 2.0 mg/kg dose, a single 3.0mg/kg dose and a 3.5 mg/kg dose when administered intra-operatively as an inhaled gas for 1 hour, by assessment of adverse events (AEs), vital signs, laboratory variables, serum carboxyhemoglobin (COHb), oxygenation, electrocardiography (ECG), and neurocognitive status in patients receiving kidney transplants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Male or female receiving a kidney transplant from any donor type
- •BMI between 16 and 36 inclusive
- •Spontaneously breathing (non-intubated) with supplemental oxygen standardized at 2 liters via nasal cannula
- •Hemodynamically stable with a systolic arterial pressure > 90 mmHg and a heart rate < 120 beats/min
- •Acceptable transplantation candidate as judged by medical history, physical exam, ECG, vital signs, clinical chemistry, hematology, and urinalysis
- •Given written and verbal information and had the opportunity to ask questions about the study
- •Signed informed consent to participate in the study
排除标准
- •Exposure to any carbon monoxide source (e.g., fire, gas, or heavily polluted air) during the 48 hours prior to the study day
- •Baseline blood level of COHb >2%
- •Baseline hemoglobin (Hb) <10.0 g/dL
- •Patients with significant underlying lung disease such as moderate or severe asthma, COPD, and interstitial lung disease
- •Baseline oxygen saturation <95%
- •Pregnancy or breastfeeding
- •Participation in other clinical trial within 2 months prior to study drug treatment
研究组 & 干预措施
1
5.97 mg/L of carbon monoxide in 30% oxygen
干预措施: Inhaled Carbon Monoxide (Drug)
2
Oxygen 30% in Nitrogen
干预措施: Inhaled Carbon Monoxide (Drug)
结局指标
主要结局
Evaluate the safety and tolerability of three carbon monoxide dose levels when administered as an inhaled gas for 1 hour in patients receiving kidney transplants
时间窗: 28 days
次要结局
- Characterize the pharmacokinetics of the inhaled carbon monoxide; Correlate the safety parameters to inhaled carbon monoxide and COHb levels; Assess laboratory values; Assess potential markers for the incidence of delayed graft function(28 days)