Overview

This trial is active, not recruiting.

Condition transplantation, organ
Sponsor Bristol-Myers Squibb
Collaborator Heidelberg University
Start date March 2012
End date April 2018
Trial size 4335 participants
Trial identifier NCT01476943, IM103-077

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Arm
Patients undergoing solid organ transplantation, whose transplant center participates in CTS and who are treated with Belatacept 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

Primary Outcomes

Measure
The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by Cytomegalovirus (CMV) serostatus
time frame: At the time of transplantation
The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus
time frame: 1 year post transplantation
The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus
time frame: 2 year post transplantation
The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus
time frame: 3 year post transplantation

Secondary Outcomes

Measure
Extent of switches to or from Belatacept within three years post transplantation, and the temporal trend in switches post regulatory approval of Belatacept
time frame: At transplantation, 12 month, 24 month and 36 month post transplantation
Characteristics of Belatacept users vs. Calcineurin inhibitor (CNIs) users at transplantation
time frame: At the time of transplantation
Characteristics of those who switch to or from Belatacept vs. those who do not switch one year post-transplant
time frame: At transplantation and 12 month post transplantation

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients who received solid organ transplantation during study period in one of the transplant centers involved in CTS

Additional Information

Official title Belatacept in Renal Transplantation: Patterns of Use Analysis Using the Collaborative Transplant Study (CTS)
Description Time Perspective: Prospective design, Retrospective data collection and analysis
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.