Kidney transplantation is the preferred treatment for most end-stage kidney disease. This
procedure is limited, however, by two major factors: 1) a shortage of donor organs and 2)
organ rejection by the recipient. The National Institute of Diabetes and Digestive and Kidney
Diseases is screening patients with kidney failure or diabetes who may be eligible for
kidney, kidney and pancreas, or islet cell transplantation.
Patients in this screening study are not offered treatment. When the screening is complete,
patients will be offered an opportunity to participate in another institute study, or, if
there are no active studies appropriate for the patient, other options will be suggested to
the primary or referring physician. Patients found eligible for a study are not obligated to
Screening for all patients typically consists of blood tests, urinalysis, electrocardiogram,
PPD tuberculosis screen and pregnancy test. Chest and kidney X-rays and other studies may be
done on patients determined eligible for a particular study, including transplantation. A
summary of all test results will be sent to the referring physician unless the patient
This protocol is designed for screening of patients with renal failure and/or diabetes who
may be eligible for kidney, kidney-pancreas, or islet cell transplantation. Its purpose is to
allow detailed investigation into the renal and endocrine function of these patients, and the
status of other organ systems that would determine their ability to safely tolerate specific
aspects of other therapeutic research protocols. After completion of this screening process,
the patient will either be offered a chance to participate in an active treatment protocol,
or if no appropriate protocol is identified, will have recommendations for other treatment
options relayed to the primary or referring physicians.
- INCLUSION CRITERIA:
Patients will be entered on this protocol at the time of their first visit to the NIH
Clinical Center Outpatient Clinic or Inpatient Services if:
The patient carries the diagnosis of a disorder for which the Transplant Branch has active
research interest, and based on information received from an outside physician, they meet
preliminary eligibility criteria for other specific research protocols.
The patient or the patient's guardian is capable of providing informed consent, and signs
the informed consent after initial counseling by clinical staff. Separate consent forms for
all interventional procedures will be obtained after explanation of the specific procedure.
History of known malignancies except basal cell carcinoma of the skin.
Inability to give legal informed consent by self or legal guardian.
Inability or willingness 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