Status:
COMPLETED
Belatacept 3 Month Post Transplant Conversion Study
Lead Sponsor:
Lorenzo Gallon
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Transplant; Failure, Kidney
EBV
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 trans...
Detailed Description
Immunosuppressive therapy with the calcineurin inhibitors (CNI) cyclosporine (CsA) and Tacrolimus (Tac), have radically changed the field of organ transplantation. Ironically, although extensively and...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Adult ≥ 18 years of age
- Male or Female
- EBV seropositive
- Recipient of renal transplant from living or deceased donor
- Exclusion Criteria
- Recipients with EBV serostatus negative or unknown
- History of acute rejection (AR) within 3 months prior to randomization
- History of positive donor specific antibodies (DSA)
- History of antibody mediated rejection
- Positive T-cell lymphocytotoxic cross match
- Proteinuria \>1 g/day or \> 0.5 g/day if diabetic
- Rejection on 3 month post-transplant screening biopsy
- BK nephropathy at 3 months post-transplant screening biopsy
- Positive pregnancy test at the time of randomization in female of child bearing potential
- History of previous transplant
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02213068
Start Date
July 1 2014
End Date
September 1 2020
Last Update
February 8 2023
Active Locations (1)
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1
Northwestern University, The Comprehensive Transplant Center
Chicago, Illinois, United States, 60611