Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant (ENLIST)

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Kidney Transplantation

Treatments: Drug: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01386359

IM103-076

Details and patient eligibility

About

To describe how Nulojix (belatacept) is used and to determine how often Post-Transplant Lymphoproliferative Disorder (PTLD), Central Nervous System (CNS) PTLD and Progressive Multifocal Leukoencephalopathy (PML), rare and serious complications of transplant treatment, occur in patients taking Nulojix (belatacept) in a real-world setting.

Full description

Time Perspective: Prospective for the majority of patients who are enrolled at the time they begin Nulojix (belatacept) treatment. Retrospective for any patients receiving Nulojix (belatacept) prior to enrollment into ENLiST Registry

Enrollment: 914 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult kidney transplant recipient (age ≥18 years at time of transplant)

• Kidney-only transplant recipient

• Positive EBV serostatus

  a) EBV serostatus negative or unknown included per the investigator discretion

• Received first dose of Nulojix (Belatacept) within ≤ 14 days of renal transplant

• Received first dose of Nulojix (Belatacept) as part of normal clinical care (i.e. not as part of a clinical trial)

Exclusion criteria

• Received Nulojix (belatacept) for non kidney transplants
• <18 years of age at time of transplant
• Received first dose of Nulojix (belatacept) as an assigned study drug under a clinical trial protocol
• EBV-serostatus negative or unknown patients, except by investigator decision
• Patient who did not receive Belatacept for de novo treatment
• Recipient of concurrent or extant non-kidney organ transplant
• Received first dose of Nulojix (belatacept) > 14 days after date of renal transplant

Trial design

914 participants in 1 patient group

Adult de novo EBV-seropositive kidney-transplant recipients

Description:

Adult de novo EBV-seropositive kidney-transplant recipients treated with Nulojix (belatacept)

Treatment:

Drug: No Intervention