Bela 8 Week Dosing

The current dosing protocol for patients who have undergone a kidney transplant requires that Belatacept be given as an infusion every 4 weeks. The investigator wants to assess if the patients who have been stable for one year after transplant can be safely transitioned to an 8-week Belatacept infusion schedule. Renal function and any episodes of acute rejection will be closely monitored.

Inclusion criteria

• Adult (age ≥18 years currently),
• First-time renal transplant recipients of either living donor or deceased donor,

• who were initiated on belatacept at the time of transplant and
• are at least one year post-transplant and off CNI therapy for at least 6 months.
• Patients at low immunologic risk, defined as

• patients with a first transplant who have a PRA < 50 against class I and class II antigens,
• no DSA (donor-specific antibodies),
• who have not had more than one episode of rejection, and
• no episodes of rejection within the last 6 months prior to enrollment, and
• no rejection with a grade of IIB or above.

Exclusion criteria

• Not first renal transplant, or multi-organ transplant recipient
• History of greater than one episode of biopsy-proven acute rejection, or of rejection of Banff 97 grade IIB or greater, or rejection within the last 6 months.
• Pregnancy (women of childbearing potential must use adequate contraception during study)
• Unwilling to receive all belatacept infusions at the Emory Transplant Center
• Calculated Glomerular Filtration Rate (GFR) less than 35.
• Serum creatinine at enrollment over 30% higher than 3 months (±4 weeks) prior to randomization
• HbA1C greater than 8 at enrollment
• Recent history of significant proteinuria (protein/Cr ratio >1)
• Non-standard belatacept dosing (e.g. dose other than 5 mg belatacept/kg body weight)
• Cellcept dose less than 500 mg po bid.
• Prednisone dose greater than 5mg po qd within 3 months of randomization
• Patients not currently taking prednisone
• Active infection, or antibiotic or antiviral drug therapy within 1 month of randomization
• Evidence of Cytomegalovirus (CMV) viremia or clinical CMV infection within last 3 months.
• Polyomavirus BK PCR (polymerase chain reaction) load greater then 4.3 (copy number greater than 20,0000) within 3 months of randomization
• Known hepatitis B surface antigen-positive or PCR-positive for hepatitis B (testing not required)
• Known HIV (human immunodeficiency virus infection) (testing not required)
• Presence of donor specific antibody by Luminex single antigen assessment, or panel reactivity (PRA) above 50%.
• History of substance abuse or psychiatric disorder not compatible with study adherence and follow up.