Organ Preservation Media Investigation - Full Text View

Sponsor:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00225472

Purpose

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

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	Organ Preservation Media Investigation

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Estimated Enrollment:	20
Study Start Date:	June 2004
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225472

Locations

United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Anthony Dalessandro, MD

University of Wisconsin Medical School

More Information

No publications provided

Study ID Numbers:	2002-566
Study First Received:	September 13, 2005
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00225472 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 22, 2009