Renal Allograft Tolerance Through Mixed Chimerism

Key Inclusion Criteria:

- Male or female 18-60 years of age

- Candidate for a living-donor renal allograft with a one haplotype identical donor
identified.

- First or second transplant with either a living donor or cadaveric transplant as the
first transplant.

- Positive serologic testing for EBV indicating past exposure.

Key Exclusion Criteria:

- ABO blood group-incompatible renal allograft.

- Evidence of anti-HLA antibody within 60 days prior to transplant as assessed by
routine methodology (AHG and/or ELISA)

- Positive testing for: HIV, hepatitis B core antigen, or hepatitis C virus or
positivity for hepatitis B surface antigen.

- Cardiac ejection fraction < 40% or clinical evidence of insufficiency.

- History of cancer other than basal cell carcinoma of the skin or carcinoma in situ of
the cervix.

- Underlying renal disease etiology with a high risk of disease recurrence in the
transplanted kidney (such as focal segmental glomerulosclerosis, type I or II
nonproliferative glomerulonephritis).

- Prior dose-limiting radiation therapy.

- Abnormal (>2 times lab normal) values for (a) liver function chemistries (ALT, AST,
AP), (b) bilirubin, (c) coagulation studies (PT, PTT).

- The presence of any medical condition that the investigator deems incompatible with
participation in the trial.