Non-Invasive Evaluation of Transplant Kidney Using OCT

Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Age Range:Any
Start Date:April 2014
End Date:December 2018

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Optical coherence tomography (OCT) is a rapidly emerging imaging modality that can function
as a type of "optical biopsy", providing non-invasive cross-sectional images of tissue
architectural morphology in situ and in real-time. This proposal will demonstrate that OCT
has the ability to provide novel and valuable histopathological information regarding donor
kidneys that can be used to predict post-transplant renal function. These investigations will
result in a major breakthrough in increasing the number of healthy kidneys available for
transplantation by making the most efficient use of available donor kidneys, eliminating the
possible use of bad donor kidneys, providing an accurate measure of expected post-transplant
renal function, and allowing better distinction between post-transplant immunological
rejection and ischemic-induced acute renal failure.

What will be assessed: Kidney pathology will be assessed. Specifically, optical coherence
tomography (OCT) will be used to observe the pathology of the kidney uriniferous tubules. The
proximal convoluted tubules that make up most of the kidney uriniferous tubules and
parenchyma in the outer cortex of the kidney (i.e., the portion of the kidney subjacent to
the outer kidney capsule) are sensitive indicators of damage to the kidneys. When damaged due
to ischemia (i.e., a lack of blood flow), these tubules swell and cellular debris is released
into the lumens of these tubules.

Why is this data important: Damage to the kidney proximal tubules, known as acute tubular
necrosis (ATN), is the most common cause of poor post-transplant kidney function following
transplant. It has been shown that determining the extent of ATN is a good indicator of
post-transplant renal function.

How will the data be collected: The histopathology describe above (i.e., the pathology of the
kidney tubules) will be collected using optical coherence tomography (OCT). OCT is a rapidly
emerging imaging modality that can function as a type of "optical biopsy", providing
non-invasive cross-sectional images of tissue architectural pathology in situ and in
real-time. OCT is similar to ultrasound, but uses light waves instead of sound waves to
obtain high-resolution imaging. The ability of OCT of obtain high-resolution images is
necessary in order to observe the pathological changes describe above (i.e., damage to the
kidney tubules). Algorithms will be developed as a result of this investigation in order to
assist in the prediction of ATN and post-transplant kidney function.

What factors will be measured to determine post-transplant kidney function: The factors that
will be used to measure post-transplant renal function include serum creatinine, BUN and
glomerular filtration rates (GFR). This data will be collected by examining the surgical and
laboratory reports for each patient. The data will be collected daily for the first two weeks
following transplant and biweekly for the next six months following transplant. Six months
following transplant, this data will be collected every 3 months until conclusion of study
(i.e., 4 years). The patient data will be stored on password-protected files on a
password-protected computer. The data will be available only to the principal investigator
and the co-investigators in this study. A nephrologist fellow who will report directly to the
principal investigator will collect the data. The principal investigator will verify data
accuracy and protocol compliance. A biostatistician who will be blinded as to patient
identity will independently analyze the data. If the data is published, only the parameters
listed above and related to post-transplant renal function will be reported. No names will be
associated with publication of the collected kidney transplant data. The principal
investigator and the biostatistician will monitor this data and any indications of potential
harm to the patient will be reported immediately to the Institutional Review Board (IRB).

Inclusion Criteria: Undergoing Kidney Transplant -

Exclusion Criteria: None
We found this trial at
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Principal Investigator: Peter M Andrews, PhD
Phone: 202-687-1228
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