Clinical trial NCT02152345: Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients
Official title: A Randomized Clinical Trial of Efficacy and Safety on the Use of Belatacept as Compared to Tacrolimus in the Setting of Rabbit Antithymocyte Globulin Induction and Rapid Steroid Discontinuation in Deceased Donor Renal Transplant Recipients With a Focus on Ameliorating Delayed Graft Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Implant or Graft; Rejection
Keywords: kidney
renal
transplant
belatacept
delayed graft function
thymoglobulin
tacrolimus
kidney function
immunosuppression
NGAL
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: New York Presbyterian Hospital-Columbia University Medical Center (NYPH-CUMC) performs nearly 250 renal transplants annually; of these approximately half are recipients of a variety of deceased donor kidneys, usually with cold ischemia time (CIT) \>24 hours leading to an approximate incidence of delayed graft function (DGF) of 50%. The main focus of this study will be to determine whether initial immunosuppression with belatacept with Thymoglobulin induction will result in lower incidence and/or more rapid disappearance of DGF than that observed in patients who receive tacrolimus based immunosuppression. NGAL determinations will bne made in the first months after transplantation to correlate with clinical DGF.

Eligibility criteria: 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 antibodies (DSA) identified at the time of transplantation
* ABO incompatible renal transplant

Primary outcomes:
measure: Number of Participants With Delayed Graft Function (DGF)
timeFrame: Up to 3 months post-transplantation
Secondary outcomes:
measure: Percentage of Participants With Allograft Survival
timeFrame: Up to 1 year post-transplantation
measure: Number of Participants With an Allograft Rejection Episode
timeFrame: Up to 1 year post-transplantation
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Up to 1 year post-transplantation
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Mark A. Hardy, MD
role: PRINCIPAL_INVESTIGATOR
References: