Clinical Trials Directory

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

TypeNameDescription
DEVICEModified 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.