Abatacept Conversion in Kidney Transplantation

Running, not enrolling · Phase 2

Conditions studied: Renal Transplant Recipient

In brief

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.

Key facts

Study ID

NCT04955366

Run by

Emory University

People needed

87

Starts

2021-09-22

Expected to finish

2026-06-01

Last updated by the study team

2025-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Emory University Hospital (EUH) — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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