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Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix (belatacept)-based Immunosuppression

Description

The major class of anti rejection drugs used for kidney transplant recipients are the Calcineurin Inhibitors which include cyclosporine and tacrolimus. These drugs have side effets including renal injury and therefore the development of newer antirejection drugs continues. One new drug recently approved for prophylaxis againts rejection in the kidney transplant recipient is belatacept. This drug works by a different mechanism of action and is given intravenously at approximately one month intervals after the initial doses. The purpose of ths study is to evaluate belatacept in renal transplant recipients who are converted from a calcineurin inhibitor to belatacept and administered the drug over a two year period. Participants will be randomized 1:1 to either remain on the calcineurin inhibitor or convert to belatacept. Both groups will receive mycophenolate mofetil (or another similar agent) and steroids which are routinely used in this patient population. Participants will be closely monitored over the next two years and for an additional period thereafter for adverse events, renal function, and rejection episodes. Post tranplant lymphoproliferative disease is a complicaton of immunosuppression and it was found in prior studies that there were more cases in patients randomized to belatacept that calcineurin inhibitorrs. In addition, there was more involved of the central nervous system. The group at greatest risk were patients who had negative serology for EBV and these were therefore excluded from studies later on. Particular attention will be paid to monitoring for post-transplant lymphoproliferative disease through exams, neurologic assessments and additonal evaluation as indicated. The sponsor will conduct the statistical analysis to compare renal function, graft survival, rejection and adverse events.

Phase

Phase 3

Inclusion and Exclusion Criteria

  • Men and women, ages 18-75 inclusive
  • 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 [Modification of Diet in Renal Disease study (MDRD) 4-formula]

  • Recipients with Epstein-Barr virus (EBV) serostatus negative or unknown
  • History of acute rejection (AR) 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

Sites

  • California

    • Keck Medical Center Of Usc, Hcc 1, Los Angeles, California, 90033
    • Transplant Research Institute, Los Angeles, California, 90057
    • Local Institution, Los Angeles, California, 90048
    • Cedars Sinai Medical Center, Los Angeles, California, 90048
    • University Of California - Los Angeles, Los Angeles, California, 90024
    • Loma Linda University Medical Center-Transplantation Institu, Loma Linda, California, 92354
    • California Institute Of Renal Research, San Diego, California, 92123
    • University Of California San Francisco, San Francisco, California, 94143
    • California Pacific Medical Center, San Francisco, California, 94115
    • University Of California Davis Medical Center, Sacramento, California, 95817
    • University Of California Davis Health System, Sacramento, California, 95817
  • Utah

    • University Of Utah, Salt Lake City, Utah, 84132
  • Colorado

    • Denver Nephrologists, Denver, Colorado, 80218
    • University Of Colorado, Aurora, Colorado, 80045
  • Washington

    • Providence Sacred Heart Medical Center, Spokane, Washington, 99204
    • University Of Washington Medical Center, Seattle, Washington, 98195
    • Swedish Medical Center, Seattle, Washington, 98104
  • Texas

    • Baylor All Saints Medical Centers, Fort Worth, Texas, 76104
    • Local Institution, Dallas, Texas, 75246
    • Annette C And Harold C Simmons Transplant Institute, Dallas, Texas, 75246
    • The Methodist Hospital, Houston, Texas, 77030
    • Local Institution, Houston, Texas, 77030
    • Local Institution, Houston, Texas, 77030
    • Baylor College Of Medicine, Houston, Texas, 77030
  • Iowa

    • Local Institution, Iowa City, Iowa, 52242
    • University Of Iowa Health Care, Iowa City, Iowa, 52242
  • Missouri

    • Local Institution, Saint Louis, Missouri, 63110
    • Washington University School Of Medicine, Saint Louis, Missouri, 63110
  • Tennessee

    • Methodist University Hospital, Memphis, Tennessee, 38104
    • Vanderbilt University Medical Center, Nashville, Tennessee, 37232
  • Wisconsin

    • University Of Wisconsin School Of Medicine & Public Health, Madison, Wisconsin, 53705
    • Medical College Of Wisconsin, Milwaukee, Wisconsin, 53226
  • Illinois

    • Local Institution, Chicago, Illinois, 60612
    • Rush University Medical Center, Chicago, Illinois, 60612
  • Alabama

    • University Of Alabama At Birmingham (Uab), Birmingham, Alabama, 35294
  • Georgia

    • Emory Transplant Center, Atlanta, Georgia, 30322
  • Germany

    • Local Institution, Wuerzburg, 97080
    • Local Institution, Wurzburg, 97080
    • Local Institution, Heidelberg, 69120
    • Local Institution, Essen, 45147
  • Sweden

    • Local Institution, Uppsala, 75185
    • Local Institution, Uppsala, 75185
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