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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Transplantation, Kidney; Kidney Transplantation

Treatments: Drug: Calcineurin inhibitors (CNI); Drug: Belatacept

Study type: Observational

Funder types: Industry

Identifiers

NCT01656343

IM103-075

Details and patient eligibility

About

• 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

Enrollment: 775 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

775 participants in 2 patient groups

Belatacept treated kidney-only transplant recipients

Treatment:

Drug: Belatacept

CNI treated kidney-only transplant recipients

Treatment:

Drug: Calcineurin inhibitors (CNI)