Patterns of Use of Belatacept: Analysis of Data From the Collaborative Transplant Study

Transplantation, Organ Clinical Trial

— CTS  

Official title:

Belatacept in Renal Transplantation: Patterns of Use Analysis Using the Collaborative Transplant Study (CTS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476943
• Other study ID #: IM103-077
• Status: Completed
• Start date: March 31, 2012
• Est. completion date: April 30, 2018

Study information

• Verified date: May 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Time Perspective: Prospective design, Retrospective data collection and analysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72392
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who received solid organ transplantation during study period in one of the transplant centers involved in CTS

Related Conditions & MeSH terms

• Transplantation, Organ

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Heidelberg University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by Cytomegalovirus (CMV) serostatus		At the time of transplantation
Primary	The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus		1 year post transplantation
Primary	The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus		2 year post transplantation
Primary	The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus		3 year post transplantation
Secondary	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
Secondary	Characteristics of Belatacept users vs. Calcineurin inhibitor (CNIs) users at transplantation		At the time of transplantation
Secondary	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

External Links

•   BMS Clinical Trials Disclosure
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form