NCT01476943

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72,392

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

March 31, 2012

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

6.1 years

First QC Date

November 8, 2011

Last Update Submit

May 3, 2018

Conditions

Transplantation, Organ

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2011

First Posted

November 22, 2011

Study Start

March 31, 2012

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

May 4, 2018

Record last verified: 2018-05