Regimen Optimization Study

Condition(s) targeted: Kidney Transplantation

Intervention: Thymoglobulin (Drug); Belatacept (Drug); mycophenolate mofetil(MMF) (Drug); Corticosteroids (Drug); Everolimus(EVL) (Drug); Tacrolimus(TAC) (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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 three immunosuppressive regimens (belatacept with mycophenolate mofetil or belatacept with everolimus, tacrolimus with mycophenolate mofetil), following thymoglobulin induction and rapid corticosteroid withdrawal.

Official title: Evaluation of Acute Rejection Rates in de Novo Renal Transplant Recipients Following Thymoglobulin Induction, CNI-free, Nulojix (Belatacept)-Based Immunosuppression

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of clinically-suspected biopsy-proven acute rejection (CSBPAR) in the individual treatment groups: Belatacept + MMF, Belatacept + EVL, TAC + MMF

Secondary outcome:

The three treatment groups will each be compared to one another for all secondary endpoints: Treatment differences, time to and outcomes following acute rejection

Proportion of subjects who are alive with a functioning graft, have died, and have lost the graft and the time to these events

Changes in renal function

Percentages of subjects with and characterization of Donor Specific Anti- human leukocyte antigen(HLA) Antibodies

Safety and tolerability of each treatment regimen

Incidence of new onset diabetes after transplant, and changes in blood pressure and blood tests for cardiovascular disease

Detailed description: Calcineurin inhibitor (CNI)

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Starting date: September 2015
Last updated: August 19, 2015