Randomized Conversion Of Epstein-Barr Virus (EBV)+ Kidney Transplant Recipients Of Living Or Standard Criteria Donors At Three Months Post Transplantation To Belatacept With MPA Or Belatacept With Low-Dose Tacrolimus (50% Of Dose) Compared To Patients Remaining On Center Specific Standard Therapy Of Tacrolimus And MPA

STU00085274

This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months after kidney transplantation. The immune system is the body's defense against infection and other disease. After transplantation, the body sees the new organ as "foreign" and tries to destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from attacking the transplanted organ. The primary purpose of this research study is to evaluate the effects of three (3) different immunosuppressive treatments on rejection in post-transplant kidney recipients. This study will test whether switching from tacrolimus to belatacept will improve long-term kidney function. Three of the immunosuppressants used in this study- mycophenolic acid (MPA), mycophenolate mofetil (MMF) and tacrolimus- are medications approved by the United States Food and Drug Administration (FDA) to be used after transplant. All of these medications have been routinely used in kidney recipients here at Northwestern University. Belatacept (the "study drug") has been approved by the FDA for use at the time of transplant. However, the use of belatacept in this study is considered investigational as it has not been FDA approved for use beginning at 3 months after transplant. This study will involve 51 adult kidney transplant recipients at Northwestern.

2014-07-01

2020-09-01

2020-09-01

Completed

Early phase I

28

Inclusion Criteria 1. Adult ≥ 18 years of age 2. Male or Female 3. EBV seropositive 4. Recipient of renal transplant from living or deceased donor Exclusion Criteria 1. Recipients with EBV serostatus negative or unknown 2. History of acute rejection (AR) within 3 months prior to randomization 3. History of positive donor specific antibodies (DSA) 4. History of antibody mediated rejection 5. Positive T-cell lymphocytotoxic cross match 6. Proteinuria \>1 g/day or \> 0.5 g/day if diabetic 7. Rejection on 3 month post-transplant screening biopsy 8. BK nephropathy at 3 months post-transplant screening biopsy 9. Positive pregnancy test at the time of randomization in female of child bearing potential 10. History of previous transplant

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}

2023-02-08