Validation of Gene Expression Markers of Renal Allograft Functional Decline



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:March 2013
End Date:March 2018

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Multicenter Validation of Gene Expression Markers of Renal Allograft Functional Decline (GEN-04)

The purpose of this study is to determine if certain genes found in a kidney biopsy performed
at one-year post transplant can predict which transplanted kidneys will have decreased kidney
function within five years post-transplant.

Gene expression profiling is used to study the activity of genes. Each gene has an "on/off"
switch that controls how they are expressed in a cell, as well as a "volume control" that
increases or decreases the level of expression of a particular gene as necessary. Researchers
want to see if the presence and abundance of certain transcripts in a kidney biopsy at one
year after transplant can predict which kidneys will have reduced function over time.

Inclusion Criteria:

- Adult (≥18 years) conventional renal transplant recipient.

- Patients who have given informed consent and are willing to comply with the protocol.

Exclusion Criteria:

- ABO incompatible kidney transplants.

- Positive crossmatch kidney transplants (T cell crossmatch >100, B flow cytometric
crossmatch >150).

- Simultaneous kidney and extra-renal organ transplants including pancreas, liver,
heart, lung, etc. Subjects who had previous extra renal transplants may be included in
the study.

- Patients taking chronic anticoagulation, which includes Coumadin, Plavix and any type
of heparin. Aspirin is acceptable but must be stopped 5 days prior to the renal
biopsy.

- An inability to have the 1-year renal biopsy performed within the acceptable protocol
window (Months 11-14 [Days 301-420] post-transplant).
We found this trial at
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Kim Dean, MD
Phone: 313-916-3709
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Thomas Gonwa, MD
Phone: 904-953-8557
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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5777 East Mayo Boulevard
Phoenix, Arizona 85054
(480) 515-6296
Principal Investigator: Kunam Reddy, MD
Phone: 480-342-3906
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Rochester, Minnesota 55905
Principal Investigator: Mark Stegall, MD
Phone: 507-538-9617
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Rochester, MN
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