Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome

Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome: Open-label, Multi-center, Single Arm, Phase 4 Trial (DoSAKOM)

Efficacy and Safety of My-Rept® (Mycophenolate Mofetil 500mg/Tab. or 250mg/Cap.) in Combination with Tacrolimus, Methylprednisolone, Simulect in Kidney Transplant Patients

This study is a multi-center, non-comparative and phase IV clinical trial that evaluates incidence of Donor-Specific Antibody for 36 months after kidney transplantation when administered with Tacrolimus, Mycophenolate mofetil, and corticosteroid

Inclusion Criteria:

1. Over 19 years old(male or female)
2. Patients who are planning to receive a kidney from a deceased or a living unrelated/related donor
3. Agreement with written informed consent

Exclusion Criteria:

1. Donor's HLA antigen matches recipient or the Degree of Mis-Match is 0

2. Patients with high sensitization who need desensitization therapy

3. Multi organ recipients or previous transplant with any organs

4. Diagnosed with cancer within five years

5. Patient who receive kidney from ABO incompatibility donor or Lymphocyte cross-match positive donor

6. Patients who have positive HIV, HBsAg or Anti-HCV test result

7. At screening

   • Under treatment for active liver disease, or Over 3times upper than normal range of liver function test (T-bilirubin, AST, ALT)
   • WBC<2,500/mm3, PLT <50,000/mm3, ANC<1,500/mm3

8. Pregnant or lactating women

9. In investigator's judgment