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Completed

NCT Number: NCT01476943

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

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.

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Key information

Conditions

Transplantation, Organ

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Time Perspective: Prospective design, Retrospective data collection and analysis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

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

    Time frame: 1 year post transplantation

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

    Time frame: 2 year post transplantation

  4. 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

  1. 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

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

    Time frame: At the time of transplantation

  3. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Heidelberg University

Registry information

Official study title

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

Acronym: CTS

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Nov 22, 2011
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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