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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Heidelberg University
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01476943
First received: November 8, 2011
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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.


Condition
Transplantation, Organ

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Belatacept in Renal Transplantation: Patterns of Use Analysis Using the Collaborative Transplant Study (CTS)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus [ Time Frame: 1 year post transplantation ] [ Designated as safety issue: No ]
  • The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus [ Time Frame: 2 year post transplantation ] [ Designated as safety issue: No ]
  • The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus [ Time Frame: 3 year post transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Characteristics of Belatacept users vs. Calcineurin inhibitor (CNIs) users at transplantation [ Time Frame: At the time of transplantation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 4335
Study Start Date: April 2012
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

Time Perspective: Prospective design, Retrospective data collection and analysis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • Patients who received solid organ transplantation during study period in one of the transplant centers involved in CTS
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476943

Sponsors and Collaborators
Bristol-Myers Squibb
Heidelberg University
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01476943     History of Changes
Other Study ID Numbers: IM103-077
Study First Received: November 8, 2011
Last Updated: September 24, 2014
Health Authority: European Union: European Medicines Agency

ClinicalTrials.gov processed this record on October 01, 2014