Organ Preservation Media Investigation

Completed · Phase 1

Conditions studied: Kidney Transplant

In brief

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.

Key facts

Study ID

NCT00225472

Run by

University of Wisconsin, Madison

People needed

20

Starts

2004-06-01

Expected to finish

2007-07-01

Last updated by the study team

2016-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• first renal transplant, PRA's <20%

You may not qualify if…

• PRA's greater than 20%
• Subjects who are receiving a non-primary renal transplant
• Subjects under the age of 18
• Pregnant or nursing women

Where it is running

• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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