Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients

Columbia University

Status and phase: Completed; Phase 4

Conditions: Implant or Graft; Rejection

Treatments: Drug: Methylprednisolone; Drug: Tacrolimus; Drug: Belatacept; Procedure: Renal transplant; Drug: Mycophenolate; Drug: rATG

Study type: Interventional

Funder types: Other

Identifiers

NCT02152345

AAAL7011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Belatacept Immunosuppression

Experimental group

Description:

Renal transplant recipients will receive steroids (Methylprednisolone), rATG, Belatacept and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.

Treatment:

Drug: rATG

Drug: Mycophenolate

Procedure: Renal transplant

Drug: Belatacept

Drug: Methylprednisolone

Standard Immunosuppression (Tacrolimus)

Active Comparator group

Description:

Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.

Treatment:

Drug: rATG

Drug: Mycophenolate

Procedure: Renal transplant

Drug: Tacrolimus

Drug: Methylprednisolone