Study of Tolerant Kidney Transplant Recipients

• To identify individuals who have received a kidney transplant and who have achieved a state of immune tolerance to graft. [ Time Frame: 0 to 8 years ] [ Designated as safety issue: No ]
• To create an electronic registry of data on the tolerant and comparison groups that will serve as the basis for statistical analyses. [ Time Frame: 0 to 8 years ] [ Designated as safety issue: No ]
• To use data from the registry to perform classical tests of hypotheses regarding the establishment of immune tolerance. [ Time Frame: 0 to 8 years ] [ Designated as safety issue: No ]
• 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. [ Time Frame: 0 to 8 years ] [ Designated as safety issue: No ]

Following kidney transplantation, one possible complication is rejection of the new kidney. This occurs because the body's immune system tries to attack (or reject) the newly transplanted kidney. After transplant, medicines known as "immunosuppressive" or "anti-rejection" drugs are given to everyone 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".

The purpose of this 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.

primary care clinic major kidney transplant programs

• Immune System Diseases
• Graft Rejection
• Kidney Transplantation

• Group 1 - kidney tolerant
• Group 2 - acceptor
  Enrollment for group 2 was closed
• Group 3 - kidney graft loss
  Enrollment for group 3 is closed
• Group 4 - kidney monotherapy
• Group 5 - kidney standard immunotherapy
  Enrollment for group 5 is closed
• Group 6 - kidney chronic rejector
  Enrollment for group 6 is closed
• Group 7 - kidney identical twin
  Enrollment for group 7 is closed
• Group 8 - living kidney donors
  Corresponding to recipients in group 1 or 4
• Group 9 - healthy controls
  Enrollment for group 9 is closed
• Group 10 - liver tolerant
  Enrollment for group 10 is closed
• Group 11 - liver standard immunotherapy
  Enrollment for group 11 is closed

Inclusion Criteria:

• Must be a renal transplant recipient or living donor
• Meet the criteria for inclusion in one of the study 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 Center for Disease Control (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 exclusion criteria, if identified to have been clinically tolerant prior to the occurrence of the excluding condition, will be enrolled and demographic data collected for the registry; however, the decision as to whether or not to collect blood, urine, and tissue samples will be deferred until the participant's condition improves and the clinically tolerant state persists.