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

This study has suspended participant recruitment.
(Clinical Hold pending additional data review and protocol amendment)
Sponsor:
Information provided by:
INO Therapeutics
ClinicalTrials.gov Identifier:
NCT00531856
First received: September 18, 2007
Last updated: August 26, 2010
Last verified: August 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
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.

Resource links provided by NLM:


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:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: August 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
5.97 mg/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
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.
Placebo Comparator: 2
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
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.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Universtiy of CA, San Francisco
San Francisco, California, United States, 94143
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
INO Therapeutics
  More Information

No publications provided

Responsible Party: Alyssa Hill, INO Therapeutics
ClinicalTrials.gov Identifier: NCT00531856     History of Changes
Other Study ID Numbers: C201
Study First Received: September 18, 2007
Last Updated: August 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by INO Therapeutics:
Kidney Transplant, Carbon Monoxide

Additional relevant MeSH terms:
Carbon Monoxide
Antimetabolites
Gasotransmitters
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014