NCT00205257

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2001

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

October 5, 2015

Status Verified

December 1, 2013

Enrollment Period

5.4 years

First QC Date

September 13, 2005

Last Update Submit

October 1, 2015

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

  • kidney biopsy pathology

    1 year

Secondary Outcomes (1)

  • urinary chemokines

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Subjects under the age of 18
  • Gender of potential subjects male or female
  • Age Limits greater than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Thomas Chin

    University of Wisconsin Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

September 1, 2001

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

October 5, 2015

Record last verified: 2013-12