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

2014-08-27 03:36:07 | BioPortfolio

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 3.5mg/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.

Study Design

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

Conditions

Kidney Transplantation

Intervention

Inhaled carbon monoxide, Inhaled carbon monoxide, Inhaled carbon monoxide, Inhaled Carbon Monoxide, Inhaled Carbon Monoxide

Location

Universtiy of CA, San Francisco
San Francisco
California
United States
94143

Status

Suspended

Source

INO Therapeutics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:36:07-0400

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