Belatacept Therapy for the Failing Renal Allograft
Condition: Failing Renal Allograft
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the safety and effectiveness of belatacept (Nulojix®) in
      preventing antibody formation in patients with chronic failing kidney transplants. This study
      is a randomized study of first-time kidney transplant patients who have worsening kidney
      function and biopsy proven grade 2 or 3 interstitial fibrosis/tubular atrophy (IF/TA).
      Patients must be eligible to get a second transplant. They must have completed or be actively
      undergoing evaluation for re-listing for a second transplant. Patients will be randomized to
      either convert to belatacept or continue on calcineurin inhibitor-based therapy.
    

Detailed description: 
      The purpose of this study is to test the safety and effectiveness of the medicine belatacept
      (Nulojix®) in preventing antibodies from forming in people with a failing kidney transplant.
      Kidney transplant patients take immunosuppression medicines to prevent kidney rejection. When
      a kidney transplant begins to fail, the immunosuppression medicines are slowly weaned. Once
      dialysis is started, the immunosuppressant medicines are usually stopped. After
      immunosuppression is stopped, some people form antibodies. Antibodies are proteins that the
      immune system makes to protect against harmful foreign substances like bacteria, viruses, or
      foreign tissues, like a transplant. High levels of antibodies can make it harder to find a
      kidney donor for that person.

      Participants will be randomized into one of the two treatment groups. One group will continue
      taking their current immunosuppression medicines. The people in the treatment group will be
      switched to belatacept (Nulojix®). Belatacept (Nulojix®) is an immunosuppression medicine
      that is approved by the U.S. Food and Drug Administration (the FDA) to prevent rejection in
      kidney transplant. Participants will stop taking calcineurin inhibitors (either cyclosporine
      or tacrolimus) or sirolimus but will keep taking other immunosuppression medicines like
      Cellcept (MMF) or azathioprine (Imuran) and prednisone. These medicines will be slowly weaned
      and will be stopped if the participant has to start dialysis. Participants will continue
      taking belatacept (Nulojix®), even while on dialysis.

      The study team will test both groups to see how many people in each group develop antibodies.
    

Intervention name(s): Belatacept; Calcineurin inhibitor therapy; Mycophenolate mofetil; prednisone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Belatacept, dosing 10mg/kg- day 0, 2 weeks, 1 month, 2 months, 3 months; subsequent doses 5mg/kg monthly through duration of trial or until retransplantation, whichever is first.; Upon enrollment, wean calcineurin inhibitor (CNI) to target tacrolimus trough of 3-5 nanogram/milliliter (ng/ml)or equivalent cyclosporine trough. Upon initiation of hemodialysis, discontinue CNI therapy over 5 days.; Continue current dose at enrollment. Upon initiation of dialysis, decrease dose by half, then discontinue 2 weeks later; Begin steroid withdrawal one month after initiation of dialysis, with monthly reduction in dose by half, with plans to discontinue prednisone by 3 months after initiation of dialysis
Other intervention name(s): Nulojix; tacrolimus; cyclosporine; Cellcept; Deltasone
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Prednisone; Abatacept; Tacrolimus; Cyclosporins; Calcineurin Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney transplant