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Sponsored by: |
University of Wisconsin, Madison |
Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00225472 |
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.
Condition | Intervention | Phase |
Kidney Transplant |
Device: Modified Viaspan |
Phase I |
MedlinePlus related topics: | Kidney Transplantation |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | Organ Preservation Media Investigation |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Wisconsin | |||||
University of Wisconsin Hospital and Clinics | |||||
Madison, Wisconsin, United States, 53792 |
University of Wisconsin, Madison |
Principal Investigator: | Anthony Dalessandro, MD | University of Wisconsin Medical School |
Study ID Numbers: | 2002-566 |
First Received: | September 13, 2005 |
Last Updated: | June 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00225472 |
Health Authority: | United States: Institutional Review Board |