Monitoring for Tolerance to Kidney or Combined Kidney-Pancreas Transplants

This protocol facilitates the development of methods for determining whether transplant
recipients have developed immune hyporesponsiveness or tolerance towards their allograft.
These methods will involve the study of peripheral blood or biopsy tissue obtained at regular
intervals from patients receiving kidney or combined kidney-pancreas allografts at the Warren
G. Magnuson Clinical Center. In addition, patients that have previously received a kidney or
combined kidney-pancreas allograft will be evaluated using assays requiring peripheral blood
mononuclear cells and/or biopsies. Assays developed under this protocol will be used in
subsequent protocols to assess the effects of immune modulating treatment regimens and may
eventually be used to direct clinical care or guide the withdrawal of immunosuppressive
agents. However, patients enrolled in this protocol will not have any change in treatment
based solely on the assays developed without being enrolled in an additional study.

- INCLUSION CRITERIA:

Candidates for a kidney or combined kidney-pancreas transplant performed at the National
Institutes of Health, or non-uremic healthy volunteers who are not on immunosuppressive
medications.

Previous recipients of kidney or combined kidney-pancreas transplants.

Recipients of kidney or combined kidney-pancreas transplants interested in participation in
the Recurrent Disease Allograft Registry.

Willingness and legal ability to give informed consent or permission from a legal guardian.

Willingness to travel to the Clinical Center for protocol specific samples to be taken, or
in some cases, the ability to send samples via overnight mail.

For transplant patients, availability of donor tissue for testing. This could include
splenic or peripheral blood lymphocytes from a cadaveric donor or a willing living donor
enrolled on the Clinical Center Living Donor Protocol who consents to periodic phlebotomy
for peripheral blood lymphocyte isolation.

EXCLUSION CRITERIA:

Inability or unwillingness to comply with protocol monitoring and therapy, including, among
others, a history of noncompliance, circumstances where compliance with protocol
requirements is not feasible due to living conditions, travel restrictions, access to
urgent medical services, or access to anti-rejection drugs after the research protocol is
completed.

Any active malignancy. Patients with primary, cutaneous basal cell or squamous cell cancers
may be enrolled providing these are appropriately eliminated prior to transplant.

Significant coagulopathy or requirement for anticoagulation therapy that would
contraindicate protocol allograft biopsies.

Platelet count less than 100,000/mm(3).