Belatacept in Kidney Transplantation of Moderately Sensitized Patients (NCT02130817) | Clinical Trial Compass
WithdrawnPhase 4
Belatacept in Kidney Transplantation of Moderately Sensitized Patients
Stopped: Organ transplant criteria made recruitment difficult. Closed with IRB 10/09/2015.
United States0Started 2014-09-24
Plain-language summary
The purpose of this study is to evaluate the safety and effectiveness of an immunosuppressive medication, Belatacept, as a replacement for a calcineurin inhibitor, in combination with a standard of care regimen of immunosuppressive medications and plasma exchange (plasmapheresis and immunoglobulin treatment) for kidney transplant patients who are moderately sensitized against their deceased donor and at-risk for delayed graft function. The hypothesis is that moderately sensitized patients who receive Belatacept treatment with the standard of care regimen will lead to lower acute rejection rates than historical controls based on assessment of standard of care biopsies and standard Banff criteria.
Who can participate
Age range
18 Years – 70 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:
* Male or female subjects 18-70 years of age
* Patient who is receiving an expanded criteria donor (ECD) or deceased cardiac donor (DCD) kidney
* Have immunodominant donor specific antibodies (DSA) 1,000 - 4,000 mean fluorescent intensity (MFI) by single bead Luminex bioassay
* Subjects must be capable of understanding the investigational nature and risks of the study and must sign a statement of informed consent
* Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion and be willing to use contraceptives for the duration of the study and for 8 weeks after the last dose of study drug Women of Child-Bearing Potential (WOCBP) includes
* Women who have experienced menarche and who have not undergone successful surgical sterilization or who are not post-menopausal
* Women using oral contraceptives, other hormonal contraceptives, or mechanical products such as intrauterine devices or barrier methods
* Women who are practicing abstinence
* Women who have a partner who is sterile (eg, due to vasectomy).
* Women must not be breast-feeding
* Male subjects must agree to use an acceptable method for contraception for the duration of the study
* Patient must have known positive Epstein-Barr virus (EBV) serostatus
Exclusion Criteria:
* Patient has previously received an organ transplant other than a kidney.
* Patient is receiving an human leukocyte antigen (HLA) identical living…
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.