Phase 3
N=13
Belatacept Therapy for the Failing Renal Allograft
Failing Renal Allograft
Bottom Line
View on ClinicalTrials.gov: NCT01921218 ↗Enrolled (actual)
13
Serious AEs
69.2%
Results posted
Jan 2021
Primary outcome: Primary: Number of Participants With Donor-specific Antibody Formation — 3; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Belatacept (Drug); Calcineurin inhibitor therapy (Drug); Mycophenolate mofetil (Drug); prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Andrew B Adams
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Donor-specific Antibody Formation |
3; 4 | — |
| SECONDARY Glomerular Filtration Rate (GFR) |
14.25; 14.5; 14.25; 11; 19.33; 10.5 | — |
| SECONDARY Time to Initiation of Dialysis |
11.75; 10.5 | — |
| SECONDARY Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies |
6; 5; 0; 2; 0; 0 | — |
| SECONDARY Number of Infectious Complications |
12; 18 | — |
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 randomized study of first-time kidney transplant patients who have worsening kidney function and biopsy proven grade 2 or 3 interstitial fibrosis/tubular atrophy (IF/TA). Patients must be eligible to get a second transplant. They must have completed or be actively undergoing evaluation for re-listing for a second transplant. Patients will be randomized to either convert to belatacept or continue on calcineurin inhibitor-based therapy.
Eligibility Criteria
Inclusion Criteria
- 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) 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 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.
Data sourced from ClinicalTrials.gov (NCT01921218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.