Safety and Tolerability Study of Inhaled Carbon Monoxide in Kidney Transplant Patients - Tabular View

Tracking Information
First Received Date ^ICMJE	September 18, 2007
Last Updated Date	May 14, 2009
Start Date ^ICMJE	August 2007
Estimated Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 14, 2008)	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 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: September 18, 2007)	Evaluate the safety and tolerability of two carbon monoxide dose levels when administered as an inhaled gas for 1 hour in patients receiving kidney transplants [ Time Frame: 28 days ]
Change History	Complete list of historical versions of study NCT00531856 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 21, 2008)	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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: September 18, 2007)	Study 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 [ Time Frame: 28 days ]

Descriptive Information
Brief Title ^ICMJE	Safety and Tolerability Study of Inhaled Carbon Monoxide in Kidney Transplant Patients
Official Title ^ICMJE	A Prospective, Multicenter, Single-Blind, Placebo-Controlled, Safety and Tolerability Study of the Effects of Carbon Monoxide for Inhalation in Patients Receiving Kidney Transplants.
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 3.5mg/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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Basic Science, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Kidney Transplantation
Intervention ^ICMJE	Drug: Inhaled carbon monoxide Drug: Inhaled Carbon Monoxide
Study Arms / Comparison Groups	Experimental: 5.97mg/L of carbon monoxide in 30% oxygen Placebo Comparator: Oxygen 30% in Nitrogen
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Suspended
Estimated Enrollment ^ICMJE	40
Estimated Completion Date	April 2009
Estimated Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00531856
Responsible Party	Alyssa Hill, INO Therapeutics
Study ID Numbers ^ICMJE	C201
Study Sponsor ^ICMJE	INO Therapeutics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	INO Therapeutics
Verification Date	May 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP