Kidney Transplant Clinical Trial
Official title:
Study of Long-term Deterioration of Kidney Allograft Function (DeKAF)
The causes of deterioration of transplanted kidney function are poorly understood. The purpose of this study is to determine the disease processes that cause transplanted kidney dysfunction and loss in patients who received a kidney either recently or over a year prior to entering this study. This study will also identify specific characteristics in kidney transplant recipients that predict whether a kidney transplant will be successful.
Over time, chronic kidney graft dysfunction progressively threatens the long-term survival of
a kidney graft. The disease processes behind graft dysfunction are unclear. However, chronic
kidney graft dysfunction is likely to be caused by certain definable factors. Such factors
may include collagens III and IV, transforming growth factor (TGF)-beta, T and B cell surface
markers, cell cycle proteins, fibronectin, and laminin. Determining what disease processes
and which specific factors are most responsible for kidney graft dysfunction may help in
designing future interventional trials for kidney transplant patients. The purpose of this
study is to determine whether clinical, laboratory, and histologic studies at the time of
initial graft dysfunction will clarify the processes and factors that lead to deterioration
and loss of a kidney graft. This is an observational study that will enroll participants who
have recently received kidney transplants (prospective cohort) and participants who have had
kidney transplants for a longer period of time and are now experiencing kidney graft
dysfunction (retrospective cohort).
The duration of this trial may differ between participants, depending on when deterioration
of kidney graft function occurs. Participants will be followed until graft loss or death.
There are no exclusive study visits associated with this study. Study data are gathered from
routine laboratory follow-up tests completed at the participant's local medical center and
from information obtained at the time of kidney biopsy. Participants may need to undergo a
kidney biopsy as clinically indicated. At the time of biopsy, participants will also undergo
urine and blood collection.
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