- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00225472
Organ Preservation Media Investigation
May 10, 2016 updated by: University of Wisconsin, Madison
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital and Clinics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anthony Dalessandro, MD, University of Wisconsin Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (Actual)
July 1, 2007
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 22, 2005
First Posted (Estimate)
September 23, 2005
Study Record Updates
Last Update Posted (Estimate)
May 12, 2016
Last Update Submitted That Met QC Criteria
May 10, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 2002-566
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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