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

This study is currently recruiting participants.
Verified by INO Therapeutics, October 2008

Sponsored by: INO Therapeutics
Information provided by: INO Therapeutics
ClinicalTrials.gov Identifier: NCT00531856
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Drug: Inhaled carbon monoxide
Drug: inhaled carbon monoxide
Phase II

MedlinePlus related topics:   Kidney Transplantation   

ChemIDplus related topics:   Carbon monoxide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Basic Science, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Prospective, Multicenter, Single-Blind, Placebo-Controlled, Safety and Tolerability Study of the Effects of Carbon Monoxide for Inhalation in Patients Receiving Kidney Transplants.

Further study details as provided by INO Therapeutics:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:   16
Study Start Date:   August 2007
Estimated Study Completion Date:   March 2009
Estimated Primary Completion Date:   March 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
5.97mg/L of carbon monoxide in 30% oxygen
Drug: Inhaled carbon monoxide
0.7 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant
Drug: Inhaled carbon monoxide
2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant
Drug: inhaled carbon monoxide
2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
Drug: Inhaled carbon monoxide
3.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
2: Placebo Comparator
Oxygen 30% in Nitrogen
Drug: Inhaled carbon monoxide
0.7 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant
Drug: Inhaled carbon monoxide
2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant
Drug: inhaled carbon monoxide
2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
Drug: Inhaled carbon monoxide
3.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant

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 either a single 0.7 mg/kg dose,a single 2.0mg/kg dose or a single 3.0mg/kg dose when administered 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531856

Contacts
Contact: Robert Small     908-238-6605     robert.small@ikaria.com    

Locations
United States, California
Universtiy of CA, San Francisco     Recruiting
      San Francisco, California, United States, 94143
      Contact: Monica Rodriguez, RN     415-476-4022     RodriguezM@surgery.ucsf.edu    
      Principal Investigator: Sandy Feng, MD, PhD            
United States, Illinois
Northwestern University     Recruiting
      Chicago, Illinois, United States, 60611
      Contact: Patrice Al-Saden, RN     312-503-1058     palsaden@northwestern.edu    
      Principal Investigator: Xunrong Luo, MD            
United States, Massachusetts
Beth Israel Deaconess Medical Center     Not yet recruiting
      Boston, Massachusetts, United States, 02215
      Contact: Robyn Chudzinski, Pharm D     617-632-9841     rchudzin@caregroup.harvard.edu    
      Principal Investigator: Douglas W Hanto, MD            

Sponsors and Collaborators
INO Therapeutics
  More Information


Responsible Party:   INO Therapeutics ( Robert Small, RN )
Study ID Numbers:   C201
First Received:   September 18, 2007
Last Updated:   October 14, 2008
ClinicalTrials.gov Identifier:   NCT00531856
Health Authority:   United States: Food and Drug Administration

Keywords provided by INO Therapeutics:
Kidney Transplant, Carbon Monoxide  

Study placed in the following topic categories:
Carbon Monoxide

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008




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