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OpenTrials
Completed

NCT Number: NCT01656343

Belatacept and Risk of Post-transplant Lymphoproliferative Disorder in US Renal Transplant Recipients

* To estimate the incidence rates of post-transplant lymphoproliferative disorder (PTLD) in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept at the time of transplantation * To estimate the incidence rates of PTLD in adult, EBV seropositive, kidney alone transplant recipients treated with calcineurin inhibitors (CNI)-based regimens at the time of transplantation * To compare the PTLD incidence rates in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept to the rates in adult, EBV seropositive, kidney alone transplant recipients treated with CNI-based regimens at the time of transplantation

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Key information

Conditions

Kidney Transplantation Transplantation, Kidney

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion criteria

  • Adult,
  • EBV seropositive, Kidney only transplant recipients initiated on belatacept and adult,
  • EBV seropositive, kidney only transplant recipients initiated on CNIs reported to the United Network for Organ Sharing (UNOS) during the period of recruiting belatacept users

Treatment and study plan

Calcineurin Inhibitors (CNI)

Drug

No Intervention

Belatacept

Drug

No Intervention

Other names: Nulojix

Primary outcomes

  1. Incidence rates of post-transplant lymphoproliferative disorder (PTLD) in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept at the time of transplantation

    Time frame: Every 6 months for up to 72 months

  2. Incidence rates of PTLD in adult, EBV seropositive, kidney alone transplant recipients treated with calcineurin inhibitors (CNI)-based regimens at the time of transplantation

    Time frame: Every 6 months for up to 72 months

  3. Ratio for PTLD incidence rates in adult, EBV seropositive, kidney alone, belatacept treated patients and adult EBV seropositive, kidney alone, CNI-treated patients at the time of transplantation

    Time frame: Every 6 months for up to 72 months

Secondary outcomes

  1. Incidence rates of PTLD in subgroups of belatacept-treated, adult, kidney alone transplant recipients defined by recipient Epstein-Barr virus (EBV) serostatus (negative or unknown) and by donor to recipient EBV serostatus

    Time frame: Every 6 months for up to 72 months

  2. Ratio for PTLD incidence rates in the belatacept-treated subgroups defined by EBV serostatus (negative or unknown) to the rates in corresponding CNI-treated subgroups

    Time frame: Every 6 months for up to 72 months

  3. Incidence rates of PTLD in subgroups of belatacept-treated, adult, kidney alone transplant recipients defined by recipient cytomegalovirus (CMV) serostatus and by donor to recipient CMV serostatus

    Time frame: Every 6 months for up to 72 months

  4. Ratio for PTLD incidence rates in the belatacept-treated subgroups defined by CMV serostatus to the rates in corresponding CNI-treated subgroups

    Time frame: Every 6 months for up to 72 months

  5. Characteristics (age, gender, weight, BMI, use of immunosuppressive medications, and type of induction medications) of PTLD cases, and the location and mortality of PTLD

    Time frame: Every 6 months for up to 72 months

    Characteristics in adult, kidney alone transplant recipients treated with belatacept at transplantation and in subgroups of these transplant recipients defined by EBV serostatus and CMV serostatus

  6. Ratio for characteristics of PTLD cases, and the location and mortality of PTLD, in adult, kidney alone transplant recipients treated with belatacept at transplantation to those treated with CNI-based regimens at transplantation

    Time frame: Every 6 months for up to 72 months

  7. Two year incidence rates of PTLD by calendar year of transplantation in adult, kidney alone transplant recipients treated with belatacept at transplantation, and in subgroups of these transplant recipients defined by EBV serostatus and by CMV serostatus

    Time frame: Every 6 months for up to 24 months

  8. Incidence rates of PTLD by immunosuppressive regimen changes in adult, kidney alone transplant recipients who switch to or from belatacept during the period from transplant to the end of one-year follow-up

    Time frame: Every 6 months for up to 12 months follow up

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Belatacept and Risk of PTLD in US Renal Transplant Recipients

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Aug 3, 2012
Registry last updated
Jul 22, 2022

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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