Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood & Urine Monitoring Study of Kidney Transplant Recipients - Transplant Proteogenomics
18 Years
N/A
Both
Kidney Transplantation
Trial Information
Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood & Urine Monitoring Study of Kidney Transplant Recipients - Transplant Proteogenomics
Kidney transplantation is a good treatment option for people with kidney disease. However,
there is still much to learn about how to best care for the transplanted kidney and keep it
working for a long time. One field of interest is how one's cellular make-up might affect
the body's immune response (body's natural defense system to illness and foreign things) to
a kidney transplant. Cellular tests, like gene expression, help doctors to study a person's
cellular traits. Gene expression is when information found in one's DNA is translated into
RNA and eventually proteins. These components are present in each of the body's cells. In
this study, researchers are trying to learn if certain changes in the RNA and proteins found
in blood, urine, or transplant biopsy tissue can detect rejection before injury can occur or
become too severe. The blood and urine tests will look for patterns in one's DNA (called
genetic markers).
This study will follow subjects for 2 years after transplant. There will be a total of 12
study visits with additional study visits if rejection occurs. The study requires additional
samples of blood, urine, and tissue to be collected during routine clinical visits and
biopsies (a procedure to remove and examine a small piece of kidney tissue).
Inclusion Criteria:
- Subjects undergoing primary or subsequent deceased-donor or living donor kidney
transplantation.
- Subject and/or parent guardian must be able to understand and provide informed
consent.
- Female subjects of childbearing potential must have a negative pregnancy test within
6 weeks of study entry.
Exclusion Criteria:
- Need for combined organ transplantation with an extra-renal organ and/or islet.
- Recipient of previous non-renal solid organ and/or islet cell transplantation.
- Infection with HCV or HIV.
- Inability or unwillingness of a participant to give written informed consent or
comply with study protocol.
- Any condition that, in the opinion of the investigator, would interfere with the
participant's ability to comply with study requirements.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
The incidence of biopsy proven acute rejection (AR) (both clinical and sub-clinical), Chronic Allograft Nephropathy/Interstitial Fibrosis and Tubular Atrophy (CAN/IFTA), and normal renal biopsy with stable, good kidney function
Outcome Time Frame:
12 and 24 months
Safety Issue:
Yes
Principal Investigator
Michael Abecassis, MD, MBA
Investigator Role:
Principal Investigator
Investigator Affiliation:
Northwestern University
Authority:
United States: Federal Government
Study ID:
DAIT CTOT-08
NCT ID:
NCT01289717
Start Date:
March 2011
Completion Date:
October 2015
Related Keywords:
- Kidney Transplantation
- Transplantation
- Kidney
- Biological Markers
Name | Location |
|---|---|
| The Cleveland Clinic | Cleveland, Ohio 44195 |
| Mayo Clinic, Division of Nephrology | Phoenix, Arizona 85054 |
| The Scripps Research Institute, Scripps Center for Organ and Cell Transplantation, | La Jolla, California 92037 |
| Northwestern University, Feinberg School of Medicine, Division of Organ Transplantation | Chicago, Illinois 60611 |
| Medical University of South Carolina, Division of Transplant | Charleston, South Carolina 29425 |
