Kidney Transplantation in Patients With Sickle Cell Disease

Sickle cell disease is a common disease in the African-American population. In sickle cell
disease red blood cells are abnormal in shape and can damage organs. In particular,
patients with sickle cell disease can have damage to the kidneys, resulting in renal
failure. The number of patients developing renal failure with sickle cell disease is
unknown. This is largely due to the high mortality of patients with sickle cell disease and
renal failure.

There are two types of renal replacement therapy available to patients with sickle cell
disease- dialysis and kidney transplantation. The best form of renal replacement therapy
has not been determined for patients with sickle cell disease and renal failure. There have
been approximately 190 renal transplants performed in the United States since 1988 in
patients with sickle cell disease. Patients do well, but do not survive as long as patients
with other causes of renal failure. It appears that patients with sickle cell disease who
meet the criteria for kidney transplantation may derive a benefit from transplantation
rather than undergoing dialysis.

We are performing this study to follow patients with sickle cell disease who have received a
renal transplant. We hope to learn the best way to manage patients with sickle cell disease
to improve both survival of the transplanted kidney and the patients.

In addition, we are studying the immune system and how it responds to receiving a kidney
transplant in sickle cell patients. We hope the information we learn about the immune
system will allow us to prevent injury to the new kidney transplant and allow for better
outcomes in sickle cell patients.

Inclusion Criteria:

1. Male or female patients between 18 and 65 years of age

2. Patients capable of understanding the purposes and risks of the study, who can give
written informed consent and who are willing to participate in and comply with the
study.

3. Women of childbearing potential must have a negative serum pregnancy test within 7
days prior to enrollment and must not be breast-feeding.

4. Patients must be diagnosed with Sickle Cell Disease (SS phenotype)

Exclusion Criteria:

1. Patients with any prior organ transplant or multi-organ transplant recipients.

2. Patients with evidence of an active systemic infection requiring the continued use of
antibiotics, evidence of an HIV infection, or the presence of a chronic active
hepatitis B or C.

3. Patients with history of malignancy in the last 5 years (except successfully treated
localized non-melanotic skin cancer)

4. Patients with active illegal drug use