Kidney Transplantation, Renal Transplant, Renal Transplantation, Transplant Rejection, Transplant Tolerance
Conditions
Keywords
Tolerance, Renal, Allograft, B Cell Signature
Brief summary
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.
Detailed description
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).
Interventions
None listed
Sponsors
Immune Tolerance Network (ITN)
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be a renal transplant recipient or living donor * Meet the criteria for inclusion in one of the study enrollment groups * Provide informed consent
Exclusion criteria
* AIDS \[includes all HIV-infected persons who have less than 200 cells/mm(3) CD4+ T-lymphocytes/microL, or a CD4+ T-lymphocyte/micro liter or a CD4+ T-lymphocyte percent of total lymphocytes less than 14, or who have been diagnosed with an AIDS-defining condition as defined by the Centers for Disease Control and Prevention (CDC) * Current malignancy requiring recent surgery, ongoing chemotherapy or radiation * Acute systemic infections within 30 days prior to enrollment * Pregnancy * Transplant of another organ Note: Patients meeting any of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To identify individuals who have received a kidney transplant and who have achieved a state of immune tolerance to graft | 0 to 11 years |
| To create an electronic registry of data on the tolerant and comparison groups that will serve as the basis for statistical analyses | 0 to 11 years |
| To use data from the registry to perform classical tests of hypotheses regarding the establishment of immune tolerance | 0 to 11 years |
| To use data from the registry to create and assess predictive statistical models to model such variables as clinical features, duration of tolerant state, and time to onset of immune sensitization | 0 to 11 years |
Countries
United States
Outcome results
None listed