Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study
Completed
- Conditions
- Kidney Transplantation
- Registration Number
- NCT01471223
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Time Perspective: Prospective design, Retrospective data collection and analysis
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
Inclusion Criteria
- 1st kidney only transplant during study, at one of the transplant centers participating in CTS, received Belatacept or a CNI at the time of transplantation
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Exclusion Criteria
- Patients with a history of malignancy
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidences of malignancy 5 years post transplantation Incidences of Post-transplant Lymphoproliferative Disorder (PTLD) 5 years post transplantation Incidences of hospitalized infections 2 years post transplantation
- Secondary Outcome Measures
Name Time Method 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 Every 6 months and 12 months Subgroups of the transplant recipients defined by donor-recipient EBV serostatus at the time of transplantation
Mortality rate of composite bacterial, fungal, viral, tuberculosis, herpes, and CMV infections 2 years post transplantation Cumulative incidence of hospitalized infections in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation Every 6 months and 12 months Hospitalized infections for the following infection groups:
1. Bacterial
2. fungal
3. Viral
4. Tuberculosis
5. Herpes and
6. Cytomegalovirus (CMV)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