Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation

Inclusion Criteria

• •Male or Female, 18-65 years of age at the time of enrollment;
• •Ability to understand and provide written informed consent;
• •Candidate for primary renal allograft from either a living or deceased-donor;
• •No known contraindications to study therapy using NULOJIX® (belatacept);
• •Female participants 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 completion of the study;
• •Flow-based PRA within last 12 months (in absence of a sensitizing event) of \< 30% as determined by each participating study center. If the subject experienced a sensitizing event after the PRA test date, then the PRA must be repeated and confirmed \<30%;
• •Negative crossmatch or a PRA of 0% on historic and admission sera as determined by each participating study center.
• •A documented negative 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.