Organ Preservation Media Investigation - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

June 5, 2008

Start Date ^ICMJE

June 2004

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00225472 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Organ Preservation Media Investigation

Official Title ^ICMJE

Organ Preservation Media Investigation

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Non-Randomized, Open Label, Active Control, Single Group Assignment

Condition ^ICMJE

Kidney Transplant

Intervention ^ICMJE

Device: Modified Viaspan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00225472

Responsible Party

Study ID Numbers ^ICMJE

2002-566

Study Sponsor ^ICMJE

University of Wisconsin, Madison

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Anthony Dalessandro, MD

University of Wisconsin Medical School

Information Provided By

University of Wisconsin, Madison

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP