Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225472
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2005-09-13
Brief Title:
Organ Preservation Media Investigation
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Organ Preservation Media Investigation
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None