Regimen Optimization Study
Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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
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 three immunosuppressive regimens (belatacept with mycophenolate mofetil or
belatacept with everolimus, tacrolimus with mycophenolate mofetil), following thymoglobulin
induction and rapid corticosteroid withdrawal.
Clinical Details
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 rejectionProportion 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)
Eligibility
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
Locations and Contacts
Additional Information
Starting date: September 2015
Last updated: August 19, 2015
|