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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01476943
First Posted: November 22, 2011
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Heidelberg University
Information provided by (Responsible Party):
Bristol-Myers Squibb
  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
Time Perspective: Other
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 ]
  • 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 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 ]
  • 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 ]

Estimated Enrollment: 4335
Actual Study Start Date: March 31, 2012
Estimated Study Completion Date: April 30, 2018
Estimated Primary Completion Date: April 30, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476943


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

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01476943     History of Changes
Other Study ID Numbers: IM103-077
First Submitted: November 8, 2011
First Posted: November 22, 2011
Last Update Posted: September 19, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents