Trial Information

Transcriptional Profiling of Kidney Tissue Obtained From Patients With Newly Identified Proteinuria, Nephrotic Syndrome or Nephritic Syndrome

The aim of the study is to evaluate in humans inflammatory and immune mediators that may
play a role in kidney damage. The investigators hypothesize that certain inflammatory and
immune mediators identified in the serum and/or urine of patients with a variety of
different renal disease states will provide prognostic information regarding their clinical
course. Furthermore, we hypothesize that RNA transcriptional profiling of renal biopsy
specimens will identify gene array patterns that provide prognostic information for various
disease states. Lastly, we hypothesize that patterns of inflammatory and immune mediators
identified in serum and/or urine may yield predictive diagnostic information in lieu of
renal biopsy. The ability to detect and quantify these mediators may lead to earlier
detection and treatment prior to the progression of Chronic Kidney Disease (CKD) to stage 4
and/or 5.

The study will evaluate serially collected serum, blood and urine over a one-year period
post kidney biopsy for both the presence of inflammatory or immune mediators. The blood,
serum and urine inflammatory and immune mediators will be correlated with the kidney
pathology gene signature. Note that all of the biopsies are conducted based upon clinical
indication and not for the purpose of the study.

Renal pathology gene signatures obtained from study subjects will be compared to "normal"
control specimens. Normal specimens will be obtained from donor transplant kidneys or
nephrectomy specimens performed on patients undergoing nephrectomy for the clinical
indication of an identified renal mass. Representative "normal" tissue will be obtained
from the nephrectomized kidney at a site distant from the renal mass.