Abatacept Conversion in Kidney Transplantation

  • STATUS
    Recruiting
  • End date
    Oct 5, 2024
  • participants needed
    86
  • sponsor
    Emory University
Updated on 5 October 2021

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.

Description

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. Research subjects will be recruited from those who were initiated on belatacept at the time of their kidney transplant and have been stable on belatacept therapy for at least 2 years post-transplant and off CNI therapy for at least 6 months.

A total of 86 subjects will be randomized in equal numbers, 43 patients in each arm. Enrollment of all 86 patients is expected to be completed within 1.5 years. All patients will be actively followed in the study for 24 months following randomization. The patient participation is projected to last a total of 3.5 years with data analysis to follow.

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.

Details
Condition Renal Transplant Recipient
Treatment Belatacept, Abatacept
Clinical Study IdentifierNCT04955366
SponsorEmory University
Last Modified on5 October 2021

Eligibility

Yes No Not Sure

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
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< 50%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

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
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