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Completed

NCT Number: NCT01471223

Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study

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.

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Key information

Conditions

Kidney Transplantation

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

  • 1st kidney only transplant during study, at one of the transplant centers participating in CTS, received Belatacept or a CNI at the time of transplantation

Exclusion criteria

  • Patients with a history of malignancy

Treatment and study plan

Primary outcomes

  1. Incidences of Post-transplant Lymphoproliferative Disorder (PTLD)

    Time frame: 5 years post transplantation

  2. Incidences of hospitalized infections

    Time frame: 2 years post transplantation

  3. Incidences of malignancy

    Time frame: 5 years post transplantation

Secondary outcomes

  1. 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

    Time frame: Every 6 months and 12 months

  2. 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

    Time frame: Every 6 months and 12 months

    Subgroups of the transplant recipients defined by donor-recipient EBV serostatus at the time of transplantation

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

    Time frame: Every 6 months and 12 months

    Hospitalized infections for the following infection groups:

    • Bacterial
    • fungal
    • Viral
    • Tuberculosis
    • Herpes and
    • Cytomegalovirus (CMV)

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

    Time frame: Every 6 months and 12 months

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

    Time frame: Every 6 months and 12 months

  6. Mortality rate of composite bacterial, fungal, viral, tuberculosis, herpes, and CMV infections

    Time frame: 2 years post transplantation

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Heidelberg University

Registry information

Official study title

Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study (CTS)

Acronym: CTS

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Nov 15, 2011
Registry last updated
Sep 19, 2017

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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