Abatacept Conversion in Kidney Transplantation (NCT04955366) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Abatacept Conversion in Kidney Transplantation
United States87 participantsStarted 2021-09-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in mean estimated GFR (eGFR) between randomization and 12 months post baseline
. 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).