An observational study in Kidney Transplantation, sponsored by Bristol-Myers Squibb. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-19.
Sponsored by Bristol-Myers Squibb · Observational
The purpose of the study is to estimate the incidence rates of Post-transplant Lymphoproliferative Disorder (PTLD), malignancy and hospitalized infections in adult kidney-only transplant recipients treated with Belatacept, and compared the incidences to the incidences in those treated with Calcineurin inhibitor (CNI) based regimens at the time of transplantation.
Time Perspective: Prospective design, Retrospective data collection and analysis
Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients undergoing 1st kidney only transplantation, whose transplant centers participate in CTS and who are treated with Belatacept or a CNI based regimen at the time of transplantation
Exclusion Criteria:
Patients receiving a 1st kidney-only transplant at a center participating in the CTS and receiving Belatacept at the time of transplantation
Patients receiving a 1st kidney-only transplant at a center participating in the CTS and receiving CNI at the time of transplantation
Incidences of Post-transplant Lymphoproliferative Disorder (PTLD)
Time frame: 5 years post transplantation
Incidences of hospitalized infections
Time frame: 2 years post transplantation
Incidences of malignancy
Time frame: 5 years post transplantation
Incidence rates of PTLD in adult subgroups of Belatacept- vs. CNI-treated, kidney-only transplant recipients defined by donor-recipient Epstein Barr virus (EBV) serostatus and by age groups
Time frame: Every 6 months and 12 months
Location, mortality, and tumor type of all PTLD cases in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation and in subgroups of these transplant recipients
Subgroups of the transplant recipients defined by donor-recipient EBV serostatus at the time of transplantation
Time frame: Every 6 months and 12 months
Cumulative incidence of hospitalized infections in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation
Hospitalized infections for the following infection groups: 1. Bacterial 2. fungal 3. Viral 4. Tuberculosis 5. Herpes and 6. Cytomegalovirus (CMV)
Time frame: Every 6 months and 12 months
Incidence rates of graft rejection in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation
Time frame: Every 6 months and 12 months
Incidence rates of graft failure in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation
Time frame: Every 6 months and 12 months
Mortality rate of composite bacterial, fungal, viral, tuberculosis, herpes, and CMV infections
Time frame: 2 years post transplantation
No study locations are listed for this record.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb