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Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based Immunosuppression

Description

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


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 Health System, Sacramento, California, 95817
    • University Of California Davis Medical Center, 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
    • Baylor College Of Medicine, Houston, Texas, 77030
    • Local Institution, Houston, Texas, 77030
    • Local Institution, Houston, Texas, 77030
    • The Methodist Hospital, Houston, Texas, 77030

  • Iowa

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