A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
- Conditions
- Kidney Transplantation
- Interventions
- Registration Number
- NCT01820572
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 446
- Men and women, ages 18-75 inclusive
- Adult recipients of a renal allograft from a living donor or a deceased donor between 6-60 months prior to enrollment
- Receiving a stable (≥1 month) regimen of Calcineurin inhibitor (CNI) [Cyclosporine A (CsA) or Tacrolimus (TAC)] with Mycophenolate mofetil (MMF) or Enteric Coated Mycophenolate Sodium (EC-MPS)/Mycophenolic acid (MPA), and corticosteroids
- Stable renal function for 12 weeks prior to enrollment without new onset proteinuria
- Calculated glomerular filtration rate (cGFR) ≥30 and ≤75 mL/min/1.73 m2 [Modification of Diet in Renal Disease study (MDRD) 4-formula]
- Recipients with Epstein-Barr virus (EBV) serostatus negative or unknown
- History of acute rejection (AR) within 3 months prior to enrollment
- History of antibody mediated rejection
- Positive T-cell lymphocytotoxic cross match
- Proteinuria >1 g/day or >0.5 g/day if diabetic
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CNI Tacrolimus Tacrolimus 4-11 ng/mL tablet orally according to package insert for 24 months Cyclosporine 50-250 ng/mL tablet orally according to package insert for 24 months CNI Cyclosporine Tacrolimus 4-11 ng/mL tablet orally according to package insert for 24 months Cyclosporine 50-250 ng/mL tablet orally according to package insert for 24 months Belatacept Belatacept Belatacept 5 mg/kg intravenous 30 minute infusion on Days 1, 15, 29, 43, 57 then every 28 days for 24 months
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Survive With a Functional Graft at 24 Months at 24 Months Percentage of participants who survive with a functional graft at 24 months post-randomization
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Survive With a Functional Graft at 12 Months at 12 Months Percentage of participants who survive with a functional graft at 12 months post-randomization
Number of Participants With a Biopsy Proven Acute Rejection (BPAR) at 12 and 24 Months The number of clinically suspected, biopsy proven acute rejection (AR) at 12 and 24 months post-randomization
includes participants with at least one cellular and/or humoral BPAR event.Number of Participants With Varying Severity of BPAR at 12 and 24 months Number of participants in each severity of clinically suspected, biopsy proven acute rejection (AR) at 12 and 24 months post-randomization
Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change at 12 and 24 months Mean change from baseline cGFR as calculated by the 4-variable MDRD equation to 12 and 24 months post-randomization - Percent Change
Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR at 12 and 24 Months Percentage of participants with \> 5% and \>10% improvement over baseline cGFR, at 12 and 24 months post-randomization
Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change at 12 and 24 months Mean change from baseline cGFR as calculated by the 4-variable MDRD equation to 12 and 24 months post-randomization - Adjusted Change
Mean Urine Protein/ Creatinine Ratio (UPCR) Up to 24 Months Urine protein/ creatinine ratio (UPCR) at baseline, 3, 6, 12 and 24 months post randomization
Mean Change From Baseline in Systolic and Diastolic Blood Pressure at 12 and 24 months Mean change in systolic and diastolic blood pressure from baseline to 12 and 24 months post randomization
Number of Antihypertensive Medications Used to Control Hypertension at baseline, 12 and 24 Months The total number of antihypertensive medications used to control hypertension
Number of Participants With Donor Specific Antibodies (DSA) at baseline, 12 and 24 months Number of participants with donor specific antibodies (DSA) at Baseline/Day 1, and Months 12 and 24 post-randomization
Mean Calculated Glomerular Filtration Rate (cGFR) up to 24 months Mean cGFR by study visit, as calculated by the 4-variable MDRD equation.
Slope Analysis of cGFR at 12 and 24 Months Slopes of cGFR as plotted from baseline as well as from Month 3, to Month 12 and Month 24 post-randomization
Slope Analysis of 1/Serum Creatinine at 12 and 24 Months Slopes of 1/serum creatinine as plotted from baseline as well as from Month 3, to Month 12 and Month 24 post-randomization
Mean Number of Symptom Occurrence and Symptom Distress up to 12 Months The frequency of symptom occurrence and symptom distress as measured with the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59R (MTSOSD-59R) at baseline, Week 6, and Months 3, 6, and 12 post-randomization.
Higher scores in the MTSOSD-59R indicate a greater symptom and symptom distress burden than lower scores.Number of Participants With an Adverse Event of Special Interest 24 Months Number of participants with an adverse event of special interests. Adverse events of special interest include:
Serious Infections, Post-Transplant Lymphoproliferative Disorder (PTLD), Progressive multifocal leukoencephalopathy (PML), Malignancies (other than PTLD) including non-melanoma skin carcinomas, Tuberculosis Infections, CNS infections, Viral Infections and Infusion related reactions.Number of Participants With Marked Laboratory Abnormalities 24 Months Number of participants with Marked Laboratory Abnormalities
Mean Change From Baseline in Vital Signs: Heart Rate at 12 and 24 months The mean change from baseline in measured heart rate
Trial Locations
- Locations (62)
Transplant Research Institute (PI Address)
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
University of Colorado Denver (PI Address)
🇺🇸Aurora, Colorado, United States
Tampa General Medicine Group
🇺🇸Tampa, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Denver Nephrologists, PC
🇺🇸Denver, Colorado, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
University of Buffalo
🇺🇸Buffalo, New York, United States
UAB Division of Nephrology
🇺🇸Birmingham, Alabama, United States
Penn Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Local Institution
🇨🇭Zurich, Switzerland
Medical College of Georgia at Augusta University
🇺🇸Augusta, Georgia, United States
Yale Medical Group
🇺🇸New Haven, Connecticut, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Carolinas Medical Center (PI Address)
🇺🇸Charlotte, North Carolina, United States
Central Pharmacy
🇺🇸Saint Petersburg, Florida, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
University of Virginia Health System (PI Address)
🇺🇸Charlottesville, Virginia, United States
CHU Rangueil
🇫🇷Toulouse Cedex 8, France
Central PA Transplant Foundation
🇺🇸Harrisburg, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
California Pacific Medical Center, Depart of Transplantation (PI Address)
🇺🇸San Francisco, California, United States
Henry Ford's Transplant Institute
🇺🇸Detroit, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
UCSF Medical Center
🇺🇸San Francisco, California, United States
RUSH University Transplant Program (PI Address)
🇺🇸Chicago, Illinois, United States
University of Wisconsin School of Medicine and Public Health (PI Address)
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Memorial Hermann - Texas Medical Center (Tmc), The University Of Texas Medical School At Houston
🇺🇸Houston, Texas, United States
Swedish Medical Center-Swedish Organ Transplant and Liver Center
🇺🇸Seattle, Washington, United States
University of Washington Medical Center (PI Address & Study Supplies Address)
🇺🇸Seattle, Washington, United States
Keck Medical Center of USC (PI Address)
🇺🇸Los Angeles, California, United States
UCLA Kidney Transplant Research Office
🇺🇸Los Angeles, California, United States
Loma Linda University Medical Center (LLUMC) - Children's Hospital - Transplantation Institute
🇺🇸Loma Linda, California, United States
California Institute Of Renal Research
🇺🇸San Diego, California, United States
Florida Hospital Transplant Institute (PI Address)
🇺🇸Orlando, Florida, United States
University of Iowa Health Care (PI Address)
🇺🇸Iowa City, Iowa, United States
University or Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Maine Transplant Program
🇺🇸Portland, Maine, United States
Recanati/Miller Transplantation Institue (PI Address)
🇺🇸New York, New York, United States
East Carolina Univ Nephrology Clin Res. Lab
🇺🇸Greenville, North Carolina, United States
Vanderbilt University Medical Center- GI Research Office
🇺🇸Nashville, Tennessee, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Medical College of WI Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
University of California, San Francisco (UCSF)-Kidney Transplant Service
🇺🇸Sacramento, California, United States
Medical University of South Carolina, SCTR Research Nexus
🇺🇸Charleston, South Carolina, United States
St. Clair Nephrology Research
🇺🇸Roseville, Michigan, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Washington Univ School of Med
🇺🇸Saint Louis, Missouri, United States
Baylor All Saints Medical Center at Ft. Worth
🇺🇸Fort Worth, Texas, United States
Methodist University Hospital Transplant Institute (PI Address)
🇺🇸Memphis, Tennessee, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
University of Utah Depart of Nephrology (PI Address)
🇺🇸Salt Lake City, Utah, United States
Providence Sacred Heart Medical Center and Childrens Hospital
🇺🇸Spokane, Washington, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States