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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00531856
Recruitment Status : Withdrawn (Clinical Hold pending additional data review and protocol amendment)
First Posted : September 19, 2007
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Tracking Information
First Submitted Date  ICMJE September 18, 2007
First Posted Date  ICMJE September 19, 2007
Last Update Posted Date October 19, 2016
Study Start Date  ICMJE August 2007
Actual Primary Completion Date August 2011   (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 ]
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
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 ]
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 3.5 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Kidney Transplantation
Intervention  ICMJE
  • 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
    3.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
  • Drug: Inhaled Carbon Monoxide
    3.5 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
  • Drug: Inhaled Carbon Monoxide
    2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant.
Study Arms  ICMJE
  • Experimental: 1
    5.97 mg/L of carbon monoxide in 30% oxygen
    Interventions:
    • Drug: Inhaled carbon monoxide
    • Drug: Inhaled carbon monoxide
    • Drug: Inhaled carbon monoxide
    • Drug: Inhaled Carbon Monoxide
    • Drug: Inhaled Carbon Monoxide
  • Placebo Comparator: 2
    Oxygen 30% in Nitrogen
    Interventions:
    • Drug: Inhaled carbon monoxide
    • Drug: Inhaled carbon monoxide
    • Drug: Inhaled carbon monoxide
    • Drug: Inhaled Carbon Monoxide
    • Drug: Inhaled Carbon Monoxide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 3, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2007)
16
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00531856
Other Study ID Numbers  ICMJE C201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mallinckrodt
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Mallinckrodt
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mallinckrodt
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP