Overview

Regimen Optimization Study

Status:
Completed
Trial end date:
2019-05-02
Target enrollment:
0
Participant gender:
All
Summary
Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress the immune system (called immunosuppressive regimens) to stop the immune system from attacking the transplanted kidney in order to limit damage to or the possibility of rejecting the transplanted kidney. The purpose of this study is to evaluate benefits and risks of two immunosuppressive regimens (belatacept with everolimus or tacrolimus with mycophenolate mofetil) following thymoglobulin induction and rapid corticosteroid withdrawal.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Abatacept
Everolimus
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Mycophenolate mofetil
Mycophenolic Acid
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone
Sirolimus
Tacrolimus
Thymoglobulin
Criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Men and women, aged 18 to 75

- Serologic test results are positive for past exposure to Epstein Barr Virus (EBV+)

- Diagnosed with end stage renal disease (ESRD) and scheduled to undergo transplantation
of a non-HLA identical, living or standard criteria deceased donor kidney

Exclusion Criteria:

- Primary cause of ESRD is: primary focal segmental glomerulosclerosis; or Type I or II
membranoproliferative glomerulonephritis; or Hemolytic Uremic Syndrome / Thrombotic
Thrombocytopenic Purpura

- Had a previous graft loss due to acute rejection

- At increased immunologic risk of graft loss due to panel reactive antibodies (PRA)
>20% or need for desensitization therapy

- Scheduled to receive a: kidney from identical twin; or paired kidney; or kidney from a
Cytomegalovirus(CMV) positive donor when recipient is CMV negative; or kidney from an
extended criteria donor

- Have a body mass index (BMI) of > 35 kg/m2 for nondiabetics or > 30 kg/m2 for
diabetics

- Diagnosed as Hepatitis B positive; or Hepatitis C positive; or HIV positive; or
currently or previously active or inadequately treated latent