Safety and Tolerability Study of Inhaled Carbon Monoxide in Kidney Transplant Patients
- Registration Number
- NCT00531856
- Lead Sponsor
- Mallinckrodt
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Inhaled Carbon Monoxide 5.97 mg/L of carbon monoxide in 30% oxygen 2 Inhaled Carbon Monoxide Oxygen 30% in Nitrogen
- Primary Outcome Measures
Name Time Method 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 28 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (3)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Universtiy of CA, San Francisco
🇺🇸San Francisco, California, United States