Kidney Transplantation Clinical Trial
Official title:
Identification and Mechanistic Investigations of Tolerant Transplant Recipients
The purpose of this multi-center (observational) registry study is to establish a database of clinical and laboratory information that may help to identify any unique characteristics of tolerant participants that differ from participants who reject their kidney after discontinuing immunosuppressive drugs.
Following kidney (renal) transplantation, one possible complication is rejection of the new
kidney. This occurs as a results of the body's immune system attacking (or rejecting) the
newly transplanted kidney. After transplant, medicines known as "immunosuppressive" or
"anti-rejection" drugs are given to transplant recipients to help prevent rejection of the
transplanted kidney. If a transplant recipient stops taking these medicines, they almost
always reject their transplanted kidney. However, in some exceptionally rare instances,
transplant recipients who stop taking these drugs do not reject their kidney, and the kidney
keeps working. The recipients are said at that point to "tolerate" the transplanted kidney,
and this condition is referred to as "tolerance".
In this study, participants will be asked to provide consent for the collection of extensive
demographic and clinical information; medical histories; and blood and urine samples. Blood
and urine samples collected will be used to perform specific assays to help define
mechanisms of tolerance.
Originally the study included 11 groups as listed; however, at present only groups 1,4, and
8 remain active. Whereas the initial study duration was 6 years, this was extended to 11
years in order to follow over more extended time a B cell signature identified for tolerant
kidney subjects and how this signature may change. (Refer to publications section: Newell,
Kirk et al, J Clin Invest. 2010).
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Observational Model: Cohort, Time Perspective: Prospective
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