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| Sponsored by: |
INO Therapeutics |
| Information provided by: | INO Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00531856 |
Purpose
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.
| Condition | Intervention | Phase |
|
Kidney Transplantation |
Drug: Inhaled carbon monoxide Drug: inhaled carbon monoxide |
Phase II |
| MedlinePlus related topics: | Kidney Transplantation |
| ChemIDplus related topics: | Carbon monoxide |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Prospective, Multicenter, Single-Blind, Placebo-Controlled, Safety and Tolerability Study of the Effects of Carbon Monoxide for Inhalation in Patients Receiving Kidney Transplants. |
| Estimated Enrollment: | 16 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
5.97mg/L of carbon monoxide in 30% oxygen
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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
2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
Drug: Inhaled carbon monoxide
3.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
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2: Placebo Comparator
Oxygen 30% in Nitrogen
|
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
2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
Drug: Inhaled carbon monoxide
3.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
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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 either a single 0.7 mg/kg dose,a single 2.0mg/kg dose or a single 3.0mg/kg dose when administered 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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Robert Small | 908-238-6605 | robert.small@ikaria.com |
| United States, California | |||||
| Universtiy of CA, San Francisco | Recruiting | ||||
| San Francisco, California, United States, 94143 | |||||
| Contact: Monica Rodriguez, RN 415-476-4022 RodriguezM@surgery.ucsf.edu | |||||
| Principal Investigator: Sandy Feng, MD, PhD | |||||
| United States, Illinois | |||||
| Northwestern University | Recruiting | ||||
| Chicago, Illinois, United States, 60611 | |||||
| Contact: Patrice Al-Saden, RN 312-503-1058 palsaden@northwestern.edu | |||||
| Principal Investigator: Xunrong Luo, MD | |||||
| United States, Massachusetts | |||||
| Beth Israel Deaconess Medical Center | Not yet recruiting | ||||
| Boston, Massachusetts, United States, 02215 | |||||
| Contact: Robyn Chudzinski, Pharm D 617-632-9841 rchudzin@caregroup.harvard.edu | |||||
| Principal Investigator: Douglas W Hanto, MD | |||||
| INO Therapeutics |
More Information
| Responsible Party: | INO Therapeutics ( Robert Small, RN ) |
| Study ID Numbers: | C201 |
| First Received: | September 18, 2007 |
| Last Updated: | October 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00531856 |
| Health Authority: | United States: Food and Drug Administration |
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