NCT00531856

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

A Prospective, Multicenter, Single-blind, Placebo-controlled, Safety and Tolerability Study of the Effects of Carbon Monoxide for Inhalation in Patients Receiving Kidney Transplants.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Inhaled carbon monoxide	0.7 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant
DRUG	Inhaled carbon monoxide	2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant
DRUG	Inhaled carbon monoxide	3.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
DRUG	Inhaled Carbon Monoxide	3.5 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
DRUG	Inhaled Carbon Monoxide	2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant.

Timeline

• Start date: 2007-08-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2007-09-19
• Last updated: 2016-10-19

Locations

3 sites across 1 country: United States