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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Kidney Transplantation

In brief

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.

Key facts

Study ID

NCT00531856

Run by

Mallinckrodt

People needed

0

Starts

2007-08-01

Expected to finish

2011-08-01

Last updated by the study team

2016-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Universtiy of CA, San Francisco — San Francisco, California, United States
• Northwestern University — Chicago, Illinois, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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