Patterns of Use of Belatacept: Analysis of Data From the Collaborative Transplant Study
Completed
- Conditions
- Transplantation, Organ
- Registration Number
- NCT01476943
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The primary purpose is to describe the pattern of Belatacept use at the time of transplant and up to three years post-transplantation for all Belatacept treated patients.
- Detailed Description
Time Perspective: Prospective design, Retrospective data collection and analysis
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72392
Inclusion Criteria
- Patients who received solid organ transplantation during study period in one of the transplant centers involved in CTS
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by Cytomegalovirus (CMV) serostatus At the time of transplantation The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus 3 year post transplantation
- Secondary Outcome Measures
Name Time Method Extent of switches to or from Belatacept within three years post transplantation, and the temporal trend in switches post regulatory approval of Belatacept At transplantation, 12 month, 24 month and 36 month post transplantation Characteristics of Belatacept users vs. Calcineurin inhibitor (CNIs) users at transplantation At the time of transplantation Characteristics of those who switch to or from Belatacept vs. those who do not switch one year post-transplant At transplantation and 12 month post transplantation