Abatacept Conversion in Kidney Transplantation

• Status: Recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Abatacept

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 donors:

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

• Patients at low immunologic risk

1. First time transplant

2. HLA antibody screen with PRA< 50%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

• 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.

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 than30% higher than at 3 months (±4 weeks) prior to randomization

• HbA1C greater than 8%within 3 months of enrollment (diabetic patients only)

• 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 then 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 50%.

• History of substance abuse or psychiatric disorder not compatible with study adherence and follow up.

• History of medical noncompliance