A Study of Nulojix® (Belatacept) as Maintenance Immunosuppression in Kidney Transplant Recipients

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 15-005983
    NCT ID: NCT01820572
    Sponsor Protocol Number: IM103116

About this study

The primary purpose of this study is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Men and women
  • Ages 18-75 
  • Adult recipients of a renal allograft from a living donor or a deceased donor between 6-60 months prior to enrollment 
  • Receiving a stable ( ≥ 1 month) regimen of Calcineurin inhibitor (CNI) [Cyclosporine A (CsA) or Tacrolimus (TAC)] with Mycophenolate mofetil (MMF) or Enteric Coated Mycophenolate Sodium (EC-MPS)/Mycophenolic acid (MPA), and corticosteroids
  • Stable renal function for 12 weeks prior to enrollment without new onset proteinuria 
  • Calculated glomerular filtration rate (cGFR) ≥ 30 and ≤ 75 mL/min/1.73 m2

Exclusion Criteria

  • Recipients with Epstein-Barr virus (EBV) serostatus negative or unknown 
  • History of acute rejection within 3 months prior to enrollment 
  • History of antibody mediated rejection 
  • Positive T-cell lymphocytotoxic cross match 
  • Proteinuria > 1 g/day or > 0.5 g/day if diabetic

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Closed for enrollment

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CLS-20206555

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