Abatacept Conversion in Kidney Transplantation
About the study
This is a single center, randomized, controlled phase 2b, conversion trial. This protocol has been developed to answer the question: Can patients be safely converted from monthly belatacept IV infusions to abatacept subcutaneous injections without a decrease in kidney function.The primary objective will be the difference in estimated GFR (eGFR) for abatacept and belatacept groups using a monthly repeated measures model between randomization and 12 months.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- 1. Adult (age ≥18 years currently)
- 2. First-time renal transplant recipients of either living donor or deceased donor
- 1. Treatment with belatacept from the time of transplant
- 2. At least 2 years post-transplant and off CNI therapy for at least 6 months
- 3. Patients at low immunologic risk
- 1. First time transplant
- 2. HLA antibody screen with PRA \< 80% against class I and class II antigens
- 3. Negative crossmatch (actual or virtual)
- 4. No donor specific anti-HLA antibody (DSA)
- 5. No more than one episode of rejection (Banff grade 1A or greater)
- 6. No episodes of rejection (borderline or greater) within the last 6 months prior to study participation
- 7. No rejection of Banff grade IIB or greater
- 4. Immunosuppression consisting of belatacept (5mg/kg q 1M), mycophenolate mofetil (at least 1000 mg daily), or equivalent mycophenolic acid (720 mg daily) or azathioprine (1- 2 mg/kg daily) dose, and prednisone 5 mg daily.
- 5. Confirmed Tb screening at the time of transplantation
EXCLUSION CRITERIA
Exclusion Criteria:
Individuals who meet any of these criteria are not eligible for enrollment as study participants:
- 1. Repeat renal transplant, or multi-organ transplant recipient
- 2. History of more than one episode of biopsy-proven acute rejection (Banff grade 1A or greater), or of any episode of rejection of Banff 97 grade IIB or greater, or any rejection (borderline or greater) within the last 6 months
- 3. Pregnancy (women of childbearing potential must use adequate contraception during study)
- 4. GFR less than 35
- 5. Serum creatinine at enrollment more than 30% higher than at 3 months (±4 weeks) prior to randomization
- 6. Recent history of clinically significant proteinuria (urinary protein/Cr ratio \>1.0)
- 7. Receiving belatacept at a dose other than 5 mg/kg body weight
- 8. Receiving mycophenolate mofetil at a dose of less than 1000 mg po QD (or mycophenolic acid or azathioprine equivalent).
- 9. Receiving prednisone at a dose greater than 5 mg po qd within 3 months of enrollment
- 10. Not currently receiving maintenance immunosuppression with prednisone
- 11. Active infection, or antibiotic or antiviral drug therapy within 1 month of randomization
- 12. Evidence of CMV viremia or clinical CMV infection within the last 3 months prior to randomization.
- 13. BK viremia of greater than 4.3 DNA log copies/mL (greater than 20,000 copies/mL) within 3 months of randomization
- 14. Known hepatitis B surface antigen-positive or PCR-positive for hepatitis B (testing not required)
- 15. Known HIV-positivity (testing not required)
- 16. Presence of donor specific antibody by Luminex single antigen bead assay, or antibody screen (% PRA) above 80%.
- 17. History of substance abuse or psychiatric disorder not compatible with study adherence and follow up.
- 18. History of medical noncompliance
- 19. Untreated latent Tb (as determined from prior Tb screening at the time of transplantation)
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Renal Transplant Recipient
Age (in years)
18+
Phase
PHASE2
Participants Needed
86
Est. Completion Date
Oct 31, 2024
Treatment Type
INTERVENTIONAL
Sponsor
Emory University
ClinicalTrials.gov NCT Identifier
NCT04955366
Study Number
IM101-884
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