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:
- Adult (age ≥18 years currently)
- First-time renal transplant recipients of either living donor or deceased donor
- Treatment with belatacept from the time of transplant
- At least 2 years post-transplant and off CNI therapy for at least 6 months
- Patients at low immunologic risk
- First time transplant
- HLA antibody screen with PRA < 80% against class I and class II antigens
- Negative crossmatch (actual or virtual)
- No donor specific anti-HLA antibody (DSA)
- No more than one episode of rejection (Banff grade 1A or greater)
- No episodes of rejection (borderline or greater) within the last 6 months prior to study participation
- No rejection of Banff grade IIB or greater
- 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.
- 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:
- Repeat renal transplant, or multi-organ transplant recipient
- 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
- Pregnancy (women of childbearing potential must use adequate contraception during study)
- GFR less than 35
- Serum creatinine at enrollment more than 30% higher than at 3 months (±4 weeks) prior to randomization
- Recent history of clinically significant proteinuria (urinary protein/Cr ratio >1.0)
- Receiving belatacept at a dose other than 5 mg/kg body weight
- Receiving mycophenolate mofetil at a dose of less than 1000 mg po QD (or mycophenolic acid or azathioprine equivalent).
- Receiving prednisone at a dose greater than 5 mg po qd within 3 months of enrollment
- Not currently receiving maintenance immunosuppression with prednisone
- Active infection, or antibiotic or antiviral drug therapy within 1 month of randomization
- Evidence of CMV viremia or clinical CMV infection within the last 3 months prior to randomization.
- BK viremia of greater than 4.3 DNA log copies/mL (greater than 20,000 copies/mL) within 3 months of randomization
- Known hepatitis B surface antigen-positive or PCR-positive for hepatitis B (testing not required)
- Known HIV-positivity (testing not required)
- Presence of donor specific antibody by Luminex single antigen bead assay, or antibody screen (% PRA) above 80%.
- History of substance abuse or psychiatric disorder not compatible with study adherence and follow up.
- History of medical noncompliance
- 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
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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