- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00205257
Prediction of Acute Rejection in Renal Transplant
October 1, 2015 updated by: University of Wisconsin, Madison
Prediction of Acute Graft Rejection by Examining Urine Chemokines in Patients With Kidney Transplant
Acute rejection is still a major risk factor affecting the prognosis of kidney transplant patients.
Alloreactive cells of the recipient infiltrate the kidney graft and cause inflammatory reaction which damages the graft structure and function.
Conventional diagnosis of acute rejection is based on clinical symptoms and kidney biopsy examination.
The clinical symptoms are a result of the kidney damage, which occurs days after the initiation of the rejection reaction.
Kidney biopsy is an invasive and expensive procedure.
It has been wished to have new parameters that can replace/supplement the conventional procedures.
Chemokines are small molecules that attract inflammatory cells.
Changes of chemokine levels in the urine may correlate with the immune status in the kidney.
A systematic study to evaluate the chemokine levels in urine and correlation with the kidney biopsy pathology will answer the question whether monitoring of urinary chemokines would be useful in predicting graft rejection/damage.
Study Overview
Status
Completed
Conditions
Study Type
Observational
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:
- One hundred subjects undergoing kidney biopsy for suspected rejection
- Forty subjects that have stable graft function with normal level of blood creatinine (No biopsy is needed at the time of sample collection).
Exclusion Criteria:
- Subjects under the age of 18
- Gender of potential subjects male or female
- Age Limits greater than 18 years of age
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?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
kidney biopsy pathology
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
urinary chemokines
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Chin, 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
September 1, 2001
Primary Completion (Actual)
February 1, 2007
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
October 5, 2015
Last Update Submitted That Met QC Criteria
October 1, 2015
Last Verified
December 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 2001-252
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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