Regimen Optimization Study

Completed · Phase 2

Conditions studied: Kidney Transplantation

In brief

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.

Key facts

Study ID

NCT02137239

Run by

Bristol-Myers Squibb

People needed

58

Starts

2015-12-31

Expected to finish

2019-05-02

Last updated by the study team

2021-06-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• California Institute Of Renal Research — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University Of Colorado — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Emory Univeristy — Atlanta, Georgia, United States
• University Of Illinois — Chicago, Illinois, United States
• Tulane Medical Center — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Saint Barnabas Medical Center — Livingston, New Jersey, United States
• Erie County Medical Center — Buffalo, New York, United States
• Wake Forest University School Of Medicine — Winston-Salem, North Carolina, United States
• Central PA Transplant Foundation — Harrisburg, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Virginia — Charlottesville, Virginia, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• Swedish Medical Center - Swedish Colon and Rectal Clinic - First Hill (Northwest Colon and Rectal Cl — Seattle, Washington, United States
• Sanatorio Parque S.A. — Rosario, Santa Fe Province, Argentina
• Clinica Privada Velez Sarsfield — Córdoba, Argentina
• Clinica De Nefrologia, Urologia Y Enf. Cardiovasculares — Sante Fe, Argentina

Full record on ClinicalTrials.gov

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