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

Mallinckrodt

Status and phase

Withdrawn

Phase 2

Conditions

Kidney Transplantation

Treatments

Drug: Inhaled Carbon Monoxide

Drug: Inhaled carbon monoxide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00531856

C201

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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