Regimen Optimization Study
Evaluation of Acute Rejection Rates in de Novo Renal Transplant Recipients Following Thymoglobulin Induction, CNI-free, Nulojix (Belatacept)-Based Immunosuppression
2 other identifiers
interventional
58
2 countries
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2015
Typical duration for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2014
CompletedFirst Posted
Study publicly available on registry
May 13, 2014
CompletedStudy Start
First participant enrolled
December 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2019
CompletedResults Posted
Study results publicly available
June 22, 2021
CompletedJune 22, 2021
May 1, 2021
3.3 years
May 12, 2014
October 14, 2020
May 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months
Number of Participants with Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6 Months
6 Months
Secondary Outcomes (27)
Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months
Up to 24 Months
Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR).
Up to 24 Months
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
At 6, 12 and 24 Months
Treatment Differences in Therapeutic Modalities
at 6, 12 and 24 Months
Number of Participants Who Survive With a Functioning Graft
At 6, 12 and 24 months
- +22 more secondary outcomes
Study Arms (2)
Belatacept + Everolimus
EXPERIMENTALThymoglobulin (i.v. infusion) induction, daily (or less frequently, as tolerated) not to exceed 10 days, to reach a total cumulative dose between 3.0 and 5.5 mg/kg; belatacept (infusion) regimen of 10 mg/kg i.v. on Day 1, Weeks 1, 2, 4, 8 and 12 post transplant and then a maintenance dose of 5 mg/kg every 4 weeks after 12 weeks post transplant; everolimus (tablet) daily dosing at 3.0 mg/day, 2 divided doses, starting on Day 3 dosing adjusted based on blood sample tests; methylprednisolone (infusion) prior to each Thymoglobulin infusion and prednisone (tablet), once methylprednisolone is no longer needed. (Corticosteroids to be discontinued by Day 7 or as soon thereafter as thymoglobulin infusions are completed)
Tacrolimus + Mycophenolate mofetil
EXPERIMENTALThymoglobulin (i.v. infusion) induction, daily (or less frequently, as tolerated) not to exceed 10 days, to reach a total cumulative dose between 3.0 and 5.5 mg/kg; tacrolimus (tablet) daily dosing beginning at 0.1 mg/kg/day, then adjusted based on blood sample tests; MMF (tablet) daily dosing between 0.5 to 2.0 g/day divided in 2 doses (up to 3 g/day if African Americans/Blacks); methylprednisolone (infusion) prior to each Thymoglobulin infusion and prednisone (tablet), once methylprednisolone is no longer needed. (Corticosteroids to be discontinued by Day 7 or as soon thereafter as thymoglobulin infusions are completed)
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
California Institute Of Renal Research
San Diego, California, 92123, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
University Of Colorado
Aurora, Colorado, 80045, United States
Yale University
New Haven, Connecticut, 06519, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Emory Univeristy
Atlanta, Georgia, 30322, United States
University Of Illinois
Chicago, Illinois, 60612, United States
Tulane Medical Center
New Orleans, Louisiana, 70112, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Erie County Medical Center
Buffalo, New York, 14215, United States
Wake Forest University School Of Medicine
Winston-Salem, North Carolina, 27157, United States
Central PA Transplant Foundation
Harrisburg, Pennsylvania, 17104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Virginia
Charlottesville, Virginia, 22908-0709, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Swedish Medical Center - Swedish Colon and Rectal Clinic - First Hill (Northwest Colon and Rectal Cl
Seattle, Washington, 98104, United States
Sanatorio Parque S.A.
Rosario, Santa Fe Province, 2000, Argentina
Clinica Privada Velez Sarsfield
Córdoba, 5016, Argentina
Clinica De Nefrologia, Urologia Y Enf. Cardiovasculares
Sante Fe, 3000, Argentina
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
One participant with BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period. Due to this, time to CSBPAR was performed using this inaccurate population, therefore inaccurate data is not presented.
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2014
First Posted
May 13, 2014
Study Start
December 31, 2015
Primary Completion
May 2, 2019
Study Completion
May 2, 2019
Last Updated
June 22, 2021
Results First Posted
June 22, 2021
Record last verified: 2021-05