Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation
Condition: Kidney Transplantation; Renal Transplantation
Intervention: Alemtuzumab; MMF; Basiliximab; Short-term Tac; tacrolimus; Belatacept; methylprednisolone
Intervention description: Induction therapy. Group 1 and 2 study therapy regimens include induction with alemtuzumab, administered as a single intravenous dose intra-operatively over a period of 2 hours.; All treatment groups (e.g., Group 1, 2 and 3): Administered at a target dose of 1000 mg by mouth twice daily beginning on the day of surgery or post operative day 1 and adjusted as clinically warranted.
Note: Myfortic® (mycophenolate sodium) may be used as a replacement for MMF, at a dose of 720 mg taken by mouth twice daily.; Induction therapy. Group 3 study therapy regimen includes induction with basiliximab, administered in two doses: 1 dose administered within 2 hours prior to transplantation surgery and the 2nd dose 4 days after transplantation (unless held due to contraindication[s]); Short-term (3 months); maintenance; maintenance; All study treatment groups: administration started on the day of transplant and tapered over a 4 day course.
Intervention MeSH terms: Mycophenolic Acid; Methylprednisolone; Alemtuzumab; Abatacept; Tacrolimus; Basiliximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: immunosuppressive (IS) regimens; long-term graft function; CNI (calcineurin Inhibitor )-free IS regimen; CNI (calcineurin Inhibitor ) IS regimen; corticosteroids

Summary:

      The purpose of this study was to assess whether a new drug, Nulojix® (belatacept), would
      minimize serious long term side effects associated with anti-rejection medications while
      still protecting the new kidney from damage. The researchers also wanted to learn more about
      the safety of this treatment and long term health of the transplanted kidney.
    

Eligibility criteria:

        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.

        Exclusion Criteria:

          -  Need for multi-organ transplant;

          -  Recipient of previous organ transplant;

          -  EBV sero-negative (or unknown) recipients;

          -  Active infection including hepatitis B, hepatitis C, or HIV;

          -  Individuals who have required treatment with prednisone or other immunosuppressive
             drugs within 1 year prior to transplant;

          -  Individuals undergoing transplant using organs from extended criteria donor (ECD) or
             donation after cardiac death (DCD) donors;

          -  HLA identical living donors;

          -  Individuals at significant risk of early recurrence of the primary renal disease
             including FSGS and MPGN type 2 or any other disease that in the opinion of the
             investigator is at increased likelihood of recurrence and which may result in rapid
             decline in renal function;

          -  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.