NCT01471223

Brief Summary

The purpose of the study is to estimate the incidence rates of Post-transplant Lymphoproliferative Disorder (PTLD), malignancy and hospitalized infections in adult kidney-only transplant recipients treated with Belatacept, and compared the incidences to the incidences in those treated with Calcineurin inhibitor (CNI) based regimens at the time of transplantation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-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 10, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

March 31, 2012

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2017

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

5.4 years

First QC Date

November 10, 2011

Last Update Submit

September 18, 2017

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (3)

  • Incidences of Post-transplant Lymphoproliferative Disorder (PTLD)

    5 years post transplantation

  • Incidences of hospitalized infections

    2 years post transplantation

  • Incidences of malignancy

    5 years post transplantation

Secondary Outcomes (6)

  • Incidence rates of PTLD in adult subgroups of Belatacept- vs. CNI-treated, kidney-only transplant recipients defined by donor-recipient Epstein Barr virus (EBV) serostatus and by age groups

    Every 6 months and 12 months

  • Location, mortality, and tumor type of all PTLD cases in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation and in subgroups of these transplant recipients

    Every 6 months and 12 months

  • Cumulative incidence of hospitalized infections in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation

    Every 6 months and 12 months

  • Incidence rates of graft rejection in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation

    Every 6 months and 12 months

  • Incidence rates of graft failure in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation

    Every 6 months and 12 months

  • +1 more secondary outcomes

Study Arms (2)

Patients receiving Belatacept in CTS

Patients receiving a 1st kidney-only transplant at a center participating in the CTS and receiving Belatacept at the time of transplantation

Patients receiving CNI in CTS

Patients receiving a 1st kidney-only transplant at a center participating in the CTS and receiving CNI 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 1st kidney only transplantation, whose transplant centers participate in CTS and who are treated with Belatacept or a CNI based regimen at the time of transplantation

You may qualify if:

  • st kidney only transplant during study, at one of the transplant centers participating in CTS, received Belatacept or a CNI at the time of transplantation

You may not qualify if:

  • Patients with a history of malignancy

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 10, 2011

First Posted

November 15, 2011

Study Start

March 31, 2012

Primary Completion

August 8, 2017

Study Completion

August 8, 2017

Last Updated

September 19, 2017

Record last verified: 2017-09