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| Name | Class |
|---|---|
| Heidelberg University | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving Belatacept in CTS | Patients receiving a 1st kidney-only transplant at a center participating in the CTS and receiving Belatacept at the time of transplantation | ||
| Patients receiving CNI in CTS | Patients receiving a 1st kidney-only transplant at a center participating in the CTS and receiving CNI at the time of transplantation |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidences of Post-transplant Lymphoproliferative Disorder (PTLD) | 5 years post transplantation | |
| Incidences of hospitalized infections | 2 years post transplantation | |
| Incidences of malignancy | 5 years post transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| Label | URL |
|---|---|
| BMS Clinical Trials Disclosure | View source |
| FDA Safety Alerts and Recalls | View source |
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Subgroups of the transplant recipients defined by donor-recipient EBV serostatus at the time of transplantation |
| 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:
| 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 | 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 | Every 6 months and 12 months |
| Mortality rate of composite bacterial, fungal, viral, tuberculosis, herpes, and CMV infections | 2 years post transplantation |