Trials / Completed
CompletedNCT00225472
Organ Preservation Media Investigation
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- University of Wisconsin, Madison · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Kidney transplantation remains limited by four problems: 1) a too high rate of delayed graft function, 2) early loss of kidneys from chronic rejection, 3) donor kidney shortages, and 4) the need for immunomodulating treatments. Improved cold storage methods can significantly impact on the first 3 of these 4 major problems. The device to be tested is a modification of the existing Viaspan organ preservation solution. The modification of this solution combines four compounds: Bovine neutrophil peptide-1 (BNP-1), Substance P (SP), Insulin-like growth factor-1 (IGF-1), and Nerve Growth Factor (NGF). This solution will be added to Viaspan for preservation of donor kidneys. Preclinical data indicates that trophic factor deprivation during cold storage is a significant and previously unrecognized mechanism of injury in cold stored kidneys. The aim of this study is improved graft function, decreasing early graft loss due to rejection, and decreasing the donor organ shortage.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Modified Viaspan |
Timeline
- Start date
- 2004-06-01
- Primary completion
- 2007-07-01
- Completion
- 2007-07-01
- First posted
- 2005-09-23
- Last updated
- 2016-05-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00225472. Inclusion in this directory is not an endorsement.