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Prediction of Acute Rejection in Renal Transplant

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ClinicalTrials.gov Identifier: NCT00205257
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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.

Condition or disease
Kidney Transplant

Study Type : Observational
Official Title: Prediction of Acute Graft Rejection by Examining Urine Chemokines in Patients With Kidney Transplant
Study Start Date : September 2001
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

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U.S. FDA Resources




Primary Outcome Measures :
  1. kidney biopsy pathology [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. urinary chemokines [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205257


Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Thomas Chin University of Wisconsin Medical School

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205257     History of Changes
Other Study ID Numbers: 2001-252
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: December 2013