Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients (NCT02152345) | Clinical Trial Compass
CompletedPhase 4
Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients
United States57 participantsStarted 2014-06
Plain-language summary
The main purpose of this study is to find out whether treatment to prevent kidney rejection with belatacept in presence of Thymoglobulin induction and withdrawal of steroids will result in less delayed graft function or "sleepy kidney" after transplant than that seen in patients who get tacrolimus as their main drug to prevent rejection instead of belatacept. The investigators will also look at whether patients who get belatacept have the same, lesser or more problems that those who get tacrolimus.
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:
* Patients must have known Epstein-Barr virus (EBV) serostatus, and that status must be positive
* Adult patients ≥18 years of age, receiving a deceased donor kidney transplant at Columbia University Medical Center (CUMC)
* Patients with a PRA ≤ of 50
* Primary or re-transplant candidates (no more than 5th renal transplant)
* Deceased donor renal transplant recipients
* Candidates eligible for rATG induction
* Patients fully consented prior to transplantation
* Women of reproductive age who are willing to delay pregnancy for the duration of the study and use appropriate recommended contraception
Exclusion Criteria:
* Seronegative or unknown EBV serologic status (due to the risk of post-transplant lymphoproliferative disorder, PTLD), predominantly involving the central nervous system.
* Patients with tuberculosis who have not been treated for latent infection.
* Scheduled to undergo multi-organ transplantation
* Recipients of previous non-renal organ transplant
* Patient receiving 5th renal transplant at the time of screening.
* Patients with a PRA \> 50
* Recipient is pre-emptive status.
* Recipient with positive flow crossmatch.
* History or known HIV
* Known hypersensitivity or contra-indications to Belatacept, Tacrolimus, Mycophenolate mofetil (cellcept), or mycophenolic acid
* Use of an investigational drug in the past 30 days before day of surgery
* Enrolled in a clinical trial other than the current
* Lactating or pregnant women
* Donor specific a…
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
Number of Participants With Delayed Graft Function (DGF)