Organ Preservation Media Investigation

Phase 1

Completed

• Conditions: Kidney Transplant

• Registration Number: NCT00225472
• Lead Sponsor: University of Wisconsin, Madison

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

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-22
• Study First Posted: 2005-09-23
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States