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

NCT00531856 | Withdrawn Phase 2 DMC

• 1 other identifier: C201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Kidney Transplantation

Keywords

Kidney Transplant, Carbon Monoxide

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

5.97 mg/L of carbon monoxide in 30% oxygen

Drug: Inhaled carbon monoxide

2

PLACEBO COMPARATOR

Oxygen 30% in Nitrogen

Drug: Inhaled carbon monoxide

Interventions

Inhaled Carbon Monoxide DRUG

0.7 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (3)

Universtiy of CA, San Francisco

San Francisco, California, 94143, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 19, 2007
• Study Start: August 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

US (3)