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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Transplantation, Organ

Phase: N/A

Status: Active, not recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Clinical Details

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

Study design: Observational Model: Cohort

Primary outcome:

The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by Cytomegalovirus (CMV) serostatus

The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus

The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus

The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus

Secondary outcome:

Extent of switches to or from Belatacept within three years post transplantation, and the temporal trend in switches post regulatory approval of Belatacept

Characteristics of Belatacept users vs. Calcineurin inhibitor (CNIs) users at transplantation

Characteristics of those who switch to or from Belatacept vs. those who do not switch one year post-transplant

Detailed description: Time Perspective: Prospective design, Retrospective data collection and analysis

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients who received solid organ transplantation during study period in one of the

transplant centers involved in CTS

Locations and Contacts

Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: March 2012
Last updated: August 11, 2015

Page last updated: August 23, 2015

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