A Trial of Two Steroid-Free Approaches Toward Mycophenolate Mofetil-Based Monotherapy Immunosuppression (Cell220)

Inclusion Criteria:

1. Patients who are male or female age 18-65 years
2. Donor age 18-65 years
3. Patients who are single-organ recipients (kidney only)
4. Women who are of childbearing potential must have a negative serum pregnancy test before transplantation and agree to use a medically acceptable method of contraception throughout the treatment period.
5. Subject (recipient) is able to understand the consent form and give written informed consent

Exclusion Criteria:

1. Known sensitivity or contraindication to sirolimus, tacrolimus or MMF
2. Patient with significant or active infection
3. Patients with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum
4. Patients with PRA > 20%
5. Patients who are pregnant or nursing mothers
6. Patients whose life expectancy is severely limited by diseases other than renal disease
7. Ongoing active substance abuse, drug or alcohol
8. Major ongoing psychiatric illness or recent history of noncompliance

9. Significant cardiovascular disease (e.g.):

   • Significant non-correctable coronary artery disease
   • Ejection fraction below 30%
   • History of recent myocardial infarction
10. Malignancy within 3 years, excluding non-melanoma skin cancers
11. Serologic evidence of infection with HIV or HBVsAg positive
12. Patients with a screening/baseline total white blood cell count < 4,000/mm3; platelet count < 100,000/mm3; triglycerides > 400 mg/dl; total cholesterol > 300 mg/dl
13. Investigational drug within 30 days prior to transplant surgery
14. Anti-T cell therapy within 30 days prior to transplant surgery
15. Patients using Prednisone
16. Patients who are ABO incompatible