Prediction of Acute Rejection in Renal Transplant

Kidney Transplant Clinical Trial

Official title:

Prediction of Acute Graft Rejection by Examining Urine Chemokines in Patients With Kidney Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205257
• Other study ID #: 2001-252
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: October 1, 2015
• Start date: September 2001
• Est. completion date: February 2007

Study information

• Verified date: December 2013
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Kidney Transplant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	kidney biopsy pathology		1 year	No
Secondary	urinary chemokines		1 year	No