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 3Inclusion 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
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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