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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00225472
Other study ID # 2002-566
Secondary ID
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. completion date
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


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, 

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