Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients

Completed · Phase 4

Conditions studied: Implant or Graft; Rejection

In brief

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.

Key facts

Study ID: NCT02152345
Run by: Columbia University
People needed: 57
Starts: 2014-06-01
Expected to finish: 2016-12-31
Last updated by the study team: 2021-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 antibodies (DSA) identified at the time of transplantation
ABO incompatible renal transplant

Where it is running

Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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