Validation of Gene Expression Markers of Renal Allograft Functional Decline

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).