Proteogenomic Biomarker Panels in a Serial Blood & Urine Monitoring Study of Kidney Transplant Recipients

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 hepatitis C virus (HCV) or human immunodeficiency virus (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.