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

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

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.

Study Overview

• Status: Completed
• Conditions: Transplantation, Organ

Detailed Description

Time Perspective: Prospective design, Retrospective data collection and analysis

• Study Type: Observational
• Enrollment (Actual): 72392

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing solid organ transplantation, whose transplant center participates in CTS and who are treated with Belatacept or a CNI based regimen at the time of transplantation

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patient treated with Belatacept at the time of transplantation; Patients undergoing solid organ transplantation, whose transplant center participates in CTS and who are treated with Belatacept at the time of transplantation
Patient treated with CNI at the time of transplantation; Patients undergoing solid organ transplantation, whose transplant center participates in CTS and who are treated with a Calcineurin inhibitor (CNI) based regimen at the time of transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	1 year post transplantation
The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus	2 year post 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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Heidelberg University

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls
• BMS Clinical Trials Disclosure

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2012
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: November 8, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (Estimate): November 22, 2011

Study Record Updates

• Last Update Posted (Actual): May 4, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IM103-077