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Prediction of Acute Rejection in Renal Transplant

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205257
First received: September 13, 2005
Last updated: February 25, 2009
Last verified: February 2009
History of Changes
  Purpose

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 Phase
Kidney Transplant
 Phase 1

Study Type: Observational
Official Title: Prediction of Acute Graft Rejection by Examining Urine Chemokines in Patients With Kidney Transplant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • kidney biopsy pathology [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • urinary chemokines [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: September 2001
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205257

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

No publications provided

ClinicalTrials.gov Identifier: NCT00205257     History of Changes
Other Study ID Numbers: 2001-252
Study First Received: September 13, 2005
Last Updated: February 25, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013