Status:
COMPLETED
Belatacept Therapy for the Failing Renal Allograft
Lead Sponsor:
Andrew B Adams
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Failing Renal Allograft
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test the safety and effectiveness of belatacept (Nulojix®) in preventing antibody formation in patients with chronic failing kidney transplants. This study is a randomi...
Detailed Description
The purpose of this study is to test the safety and effectiveness of the medicine belatacept (Nulojix®) in preventing antibodies from forming in people with a failing kidney transplant. Kidney transpl...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Kidney transplant recipient (human leukocyte antigen (HLA) non-identical donor) who now has impaired renal allograft function with:
- Estimated glomerular filtration rate (GFR) \< 35 with a decline in GFR of \> 10% in the 12 months prior to enrollment and must have biopsy proven grade II or III interstitial fibrosis/tubular atrophy (IF/TA) OR
- Estimated GFR persistently \< 20 ml/min over the 6 month period prior to enrollment absent other causes for graft dysfunction, and deemed to have a failing allograft by the patient's transplant nephrologist
- On a maintenance immunosuppressive regimen that includes calcineurin inhibitor (CNI)(tacrolimus or cyclosporine) or sirolimus and at least
- MMF of a dose of at least 1 gm/day or comparable dose of azathioprine OR
- Prednisone at a dose of at least 5 mg/day
- Men and women, ages 18 to 70, inclusive
Exclusion
- Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test.
- Sexually active fertile men not using effective birth control if their partners are WOCBP.
- Subjects who are Epstein-Barr Virus (EBV) seronegative.
- Subjects with any prior solid organ (e.g., heart, liver, pancreas) or cell (e.g., islet, bone marrow) transplant other than a renal allograft. Exception may be made for recipient of a simultaneous kidney-pancreas transplant who had previously experienced graft loss of the pancreas allograft due to thrombosis or rejection.
- Subjects with presence of donor specific antibody at the time of enrollment
- Subjects who have a recent history (within 1 yr) of biopsy proven acute rejection \> Banff grade Ia
- Subjects who have a living donor identified for re-transplant within 3 months
- Subjects with a history of post-transplant lymphoproliferative disease (PTLD)
- Subjects at risk for tuberculosis (TB)
- Subjects with a history of cancer within the past 3 years, other than non-melanoma skin cancer(s)
- Subjects with a positive BK virus serum polymerase chain reaction (PCR) \> 20,000 copies at the time of enrollment OR history of biopsy-proven BK nephropathy within the year prior to enrollment.
- Subjects with a mammogram that is suspicious for malignancy and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations
- Subjects who have difficult intravenous access or other reasons that would likely preclude the ability to receive long-term intravenous infusions
- Hypersensitivity to any medications that will be used in the protocol
- Subjects who have used any investigational drug within the 30 days prior to anticipated enrollment
- Subjects currently receiving belatacept as part of their maintenance immunosuppressive regimen
- Prisoners, or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01921218
Start Date
August 1 2013
End Date
December 12 2019
Last Update
January 26 2021
Active Locations (1)
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1
Emory University
Atlanta, Georgia, United States, 30322