Clinical trial NCT02137239: Regimen Optimization Study
Official title: Evaluation of Acute Rejection Rates in de Novo Renal Transplant Recipients Following Thymoglobulin Induction, CNI-free, Nulojix (Belatacept)-Based Immunosuppression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Transplantation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-05-13
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Calcineurin inhibitor (CNI)

Eligibility 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

Primary outcomes:
measure: Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months
timeFrame: 6 Months
Secondary outcomes:
measure: Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months
timeFrame: Up to 24 Months
measure: Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR).
timeFrame: Up to 24 Months
measure: Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
timeFrame: At 6, 12 and 24 Months
measure: Treatment Differences in Therapeutic Modalities
timeFrame: at 6, 12 and 24 Months
measure: Number of Participants Who Survive With a Functioning Graft
timeFrame: At 6, 12 and 24 months
measure: Number of Participants Deaths Post Transplant
timeFrame: up to 24 months
measure: Number of Participants Who Experience Graft Loss Post Transplant
timeFrame: At 6, 12 and 24 months
measure: Time to Event: Graft Loss and Death
timeFrame: Up to 728 Days
measure: Absolute Calculated Glomerular Filtration Rate (cGFR): Mean
timeFrame: Up 24 Months post-transplant
measure: Median Calculated Glomerular Filtration Rate (cGFR)
timeFrame: Up 24 Months post-transplant
measure: Mean Change From Month 3 in cGFR
timeFrame: Up 24 Months post-transplant
measure: Urine Protein Creatinine Ratio (UPr/Cr)
timeFrame: Up 24 Months post-transplant
measure: Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)
timeFrame: Up to 24 Months
measure: Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)
timeFrame: Up to 24 Months
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to 24 months Post-Transplant
measure: Percentage of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 24 months Post-Transplant
measure: Percentage of Participants With Events of Special Interest (ESIs)
timeFrame: Up to 24 Months
measure: Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
timeFrame: At 24 Months
measure: Mean and Mean Change From Baseline in Blood Glucose
timeFrame: Up to 24 months
measure: Mean and Mean Change From Baseline in Whole Blood HbA1c
timeFrame: Up to 24 months
measure: Percentage of Participants With New Onset Diabetes After Transplant
timeFrame: up to 24 months
measure: Absolute Values of Blood Pressure: Mean
timeFrame: Up to 24 Months
measure: Absolute Values of Blood Pressure: Median
timeFrame: Up to 24 Months
measure: Mean Changes From Baseline Values for Blood Pressure
timeFrame: Up to 24 Months
measure: Absolute Values of Fasting Lipid Values: Mean
timeFrame: Up to 24 Months
measure: Absolute Values of Fasting Lipid Values: Median
timeFrame: Up to 24 Months
measure: Mean Changes From Baseline Values of Lipid Values
timeFrame: at months 12 and 24
Other outcomes:
Locations:
city: San Diego
country: United States
facility: California Institute Of Renal Research
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Aurora
country: United States
facility: University Of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Atlanta
country: United States
facility: Emory Univeristy
state: Georgia
city: Chicago
country: United States
facility: University Of Illinois
state: Illinois
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University School Of Medicine
state: North Carolina
city: Harrisburg
country: United States
facility: Central PA Transplant Foundation
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center - Swedish Colon and Rectal Clinic - First Hill (Northwest Colon and Rectal Cl
state: Washington
city: Rosario
country: Argentina
facility: Sanatorio Parque S.A.
state: Santa Fe
city: Cordoba
country: Argentina
facility: Clinica Privada Velez Sarsfield
city: Sante Fe
country: Argentina
facility: Clinica De Nefrologia, Urologia Y Enf. Cardiovasculares
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: