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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
446
Percentage of Participants Who Survive With a Functional Graft at 24 Months
Percentage of participants who survive with a functional graft at 24 months post-randomization
Time frame: at 24 Months
Percentage of Participants Who Survive With a Functional Graft at 12 Months
Percentage of participants who survive with a functional graft at 12 months post-randomization
Time frame: at 12 Months
Number of Participants With a Biopsy Proven Acute Rejection (BPAR)
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.
Time frame: at 12 and 24 Months
Number of Participants With Varying Severity of BPAR
Number of participants in each severity of clinically suspected, biopsy proven acute rejection (AR) at 12 and 24 months post-randomization
Time frame: at 12 and 24 months
Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change
Mean change from baseline cGFR as calculated by the 4-variable MDRD equation to 12 and 24 months post-randomization - Percent Change
Time frame: at 12 and 24 months
Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change
Mean change from baseline cGFR as calculated by the 4-variable MDRD equation to 12 and 24 months post-randomization - Adjusted Change
Time frame: at 12 and 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UAB Division of Nephrology
Birmingham, Alabama, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Loma Linda University Medical Center (LLUMC) - Children's Hospital - Transplantation Institute
Loma Linda, California, United States
UCLA Kidney Transplant Research Office
Los Angeles, California, United States
Keck Medical Center of USC (PI Address)
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Transplant Research Institute (PI Address)
Los Angeles, California, United States
University of California, San Francisco (UCSF)-Kidney Transplant Service
Sacramento, California, United States
California Institute Of Renal Research
San Diego, California, United States
California Pacific Medical Center, Depart of Transplantation (PI Address)
San Francisco, California, United States
...and 107 more locations
Mean Calculated Glomerular Filtration Rate (cGFR)
Mean cGFR by study visit, as calculated by the 4-variable MDRD equation.
Time frame: up to 24 months
Slope Analysis of cGFR
Slopes of cGFR as plotted from baseline as well as from Month 3, to Month 12 and Month 24 post-randomization
Time frame: at 12 and 24 Months
Slope Analysis of 1/Serum Creatinine
Slopes of 1/serum creatinine as plotted from baseline as well as from Month 3, to Month 12 and Month 24 post-randomization
Time frame: at 12 and 24 Months
Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR
Percentage of participants with \> 5% and \>10% improvement over baseline cGFR, at 12 and 24 months post-randomization
Time frame: at 12 and 24 Months
Mean Urine Protein/ Creatinine Ratio (UPCR)
Urine protein/ creatinine ratio (UPCR) at baseline, 3, 6, 12 and 24 months post randomization
Time frame: Up to 24 Months
Mean Change From Baseline in Systolic and Diastolic Blood Pressure
Mean change in systolic and diastolic blood pressure from baseline to 12 and 24 months post randomization
Time frame: at 12 and 24 months
Number of Antihypertensive Medications Used to Control Hypertension
The total number of antihypertensive medications used to control hypertension
Time frame: at baseline, 12 and 24 Months
Number of Participants With Donor Specific Antibodies (DSA)
Number of participants with donor specific antibodies (DSA) at Baseline/Day 1, and Months 12 and 24 post-randomization
Time frame: at baseline, 12 and 24 months
Mean Number of Symptom Occurrence and Symptom Distress
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.
Time frame: up to 12 Months
Number of Participants With an Adverse Event of Special Interest
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.
Time frame: 24 Months
Number of Participants With Marked Laboratory Abnormalities
Number of participants with Marked Laboratory Abnormalities
Time frame: 24 Months
Mean Change From Baseline in Vital Signs: Heart Rate
The mean change from baseline in measured heart rate
Time frame: at 12 and 24 months