Phase 4
N=57
Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients
Implant or Graft; Rejection
Bottom Line
View on ClinicalTrials.gov: NCT02152345 ↗Enrolled (actual)
57
Serious AEs
60.4%
Results posted
Sep 2019
Primary outcome: Primary: Number of Participants With Delayed Graft Function (DGF) — 12; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Belatacept (Drug); Tacrolimus (Drug); Mycophenolate (Drug); rATG (Drug); Methylprednisolone (Drug); Renal transplant (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Delayed Graft Function (DGF) |
12; 15 | — |
| SECONDARY Percentage of Participants With Allograft Survival |
24; 21 | — |
| SECONDARY Number of Participants With an Allograft Rejection Episode |
7; 11 | — |
| SECONDARY Estimated Glomerular Filtration Rate (eGFR) |
46; 41 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02152345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.