Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/9/2018 |
| Start Date: | June 2014 |
| End Date: | December 31, 2016 |
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
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.
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.
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.
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.
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
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