Optimization of NULOJIX® Usage Towards Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation
Condition: Simultaneous Kidney and Pancreas Transplantation
Intervention: Belatacept; methylprednisolone; Anti-thymocyte Globulin (Rabbit); Tacrolimus; Mycophenolate mofetil
Intervention description: The first dose of belatacept will be administered approximately 24-48 hours after the last dose of Anti-Thymocyte Globulin (Rabbit).; There may be an opportunity to withdraw tacrolimus at week 40; Mycophenolate mofetil will be administered at a target dose of 1000 mg by mouth twice daily (e.g., BID) beginning on the day of surgery or post-operative day 1 depending upon when during the day the surgery is completed (maximum MMF dosing is 2G per day). MMF will be adjusted based on clinical complications (such as neutropenia). Myfortic® (mycophenolate sodium) may be used as a replacement for MMF. Mycophenolate sodium will be dosed at 720 mg PO BID. Mycophenolate sodium will be adjusted based on clinical complications.
Intervention MeSH terms: Mycophenolic Acid; Methylprednisolone; Abatacept; Tacrolimus; Thymoglobulin; Antilymphocyte Serum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: transplantation; kidney; pancreas; immunosuppression; calcineurin inhibitor (CNI)

Summary:

      The purpose of this study is to find out if the drug NULOJIX® (belatacept) will minimize the
      amount of other anti-rejection medications necessary and thereby reduce the long-term side
      effects caused by the other medications. The researchers also want to learn more about the
      safety of this treatment and long term health of transplanted pancreases and kidneys.
    

Eligibility criteria:

        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 treatment with systemic prednisone or other
             immunosuppressive drugs within 1 year prior to transplant;

          -  Individuals previously treated with NULOJIX® (belatacept);

          -  Any condition that, in the opinion of the investigator, would interfere with the
             participant's ability to comply with study requirements;

          -  Use of investigational drugs within 4 weeks of enrollment;

          -  Known hypersensitivity to mycophenolate mofetil (MMF)or any of the drug's components;

          -  Administration of live attenuated vaccine(s) within 8 weeks of enrollment.