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

Kidney Transplantation Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00531856
• Other study ID #: C201
• Status: Withdrawn
• Phase: Phase 2
• First received: September 18, 2007
• Last updated: October 18, 2016
• Start date: August 2007
• Est. completion date: August 2011

Study information

• Verified date: October 2016
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Inhaled carbon monoxide
0.7 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant
• Inhaled carbon monoxide
2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant
• Inhaled carbon monoxide
3.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
• Inhaled Carbon Monoxide
3.5 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
• Inhaled Carbon Monoxide
2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Universtiy of CA, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No