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

NCT00531856 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-10-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00531856 on ClinicalTrials.gov