Clinical trial NCT01656343: Belatacept and Risk of Post-transplant Lymphoproliferative Disorder in US Renal Transplant Recipients
Official title: Belatacept and Risk of PTLD in US Renal Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Transplantation, Kidney
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-08-03
Enrollment: 775
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult, EBV seropositive, kidney only transplant recipients initiated on belatacept and adult, EBV seropositive, kidney only transplant recipients initiated on CNIs reported to the UNOS during the period of recruiting belatacept users

Brief summary: * 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


Eligibility criteria: 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

Primary outcomes:
measure: Incidence rates of post-transplant lymphoproliferative disorder (PTLD) in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept at the time of transplantation
timeFrame: Every 6 months for up to 72 months
measure: Incidence rates of PTLD in adult, EBV seropositive, kidney alone transplant recipients treated with calcineurin inhibitors (CNI)-based regimens at the time of transplantation
timeFrame: Every 6 months for up to 72 months
measure: 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
timeFrame: Every 6 months for up to 72 months
Secondary outcomes:
measure: 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
timeFrame: Every 6 months for up to 72 months
measure: 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
timeFrame: Every 6 months for up to 72 months
measure: 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
timeFrame: Every 6 months for up to 72 months
measure: Ratio for PTLD incidence rates in the belatacept-treated subgroups defined by CMV serostatus to the rates in corresponding CNI-treated subgroups
timeFrame: Every 6 months for up to 72 months
measure: Characteristics (age, gender, weight, BMI, use of immunosuppressive medications, and type of induction medications) of PTLD cases, and the location and mortality of PTLD
timeFrame: Every 6 months for up to 72 months
measure: 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
timeFrame: Every 6 months for up to 72 months
measure: 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
timeFrame: Every 6 months for up to 24 months
measure: 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
timeFrame: Every 6 months for up to 12 months follow up
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: