Organ Preservation Media Investigation

Kidney Transplant Clinical Trial

Official title:

Organ Preservation Media Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225472
• Other study ID #: 2002-566
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: October 1, 2015
• Start date: June 2004

Study information

• Verified date: June 2008
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• first renal transplant, PRA's <20%

Exclusion Criteria:

• PRA's greater than 20%

• Subjects who are receiving a non-primary renal transplant

• Subjects under the age of 18

• Pregnant or nursing women

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Device:
• Modified Viaspan

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States,