Optimization of NULOJIX® Usage Towards Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation

Inclusion Criteria: * Ability to understand and provide written informed consent; * Candidate for a primary simultaneous kidney and pancreas allograft with random c-peptide \<0.3 ng/mL; * No known contraindications to study therapy using NULOJIX® (belatacept); * Female subjects of childbearing potential must have a negative pregnancy test upon study entry; * Female and male participants with reproductive potential must agree to use FDA approved methods of birth control during participation in the study and for 4 months following study completion; * No donor specific antibodies prior to transplant that are considered to be of clinical significance by the site investigator; * Negative crossmatch, actual or virtual, or a Panel Reactive Antibodies (PRA) of 0% on historic and admission sera, as determined by each participating study center; * A documented negative Tuberculosis (TB) test within the 12 months prior to transplant. If documentation is not present at the time of transplantation, and the subject does not have any risk factors for TB, a TB-specific interferon gamma release assay (IGRA) may be performed. Exclusion Criteria: * Need for multi-organ transplantation other than a kidney and pancreas; * Recipient of previous organ transplant; * Epstein-Barr Virus (EBV) sero-negative recipients or recipients whose EBV serostatus is unknown prior to the time of transplantation; * Individuals infected by the hepatitis B or C viruses or HIV; * Individuals who have required treat…