Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Evaluating Nulojix Long-Term Safety in Transplant

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: No Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult de novo EBV-seropositive kidney-transplant recipients<br>Adult de novo EBV-seropositive kidney-transplant recipients treated with Nulojix (belatacept) | Drug: No Intervention<br>* No Intervention. Subjects are previously treated with Nulojix (belatacept)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of confirmed PTLD in US adult de novo Epstein Barr Virus (EBV)-seropositive kidney transplant recipients treated with Nulojix (belatacept) in clinical practice |  | Every 6 months for up to 72 months | 
| Incidence rate of confirmed CNS PTLD in US adult de novo Epstein Barr Virus (EBV)-seropositive kidney transplant recipients treated with Nulojix (belatacept) in clinical practice |  | Every 6 months for up to 72 months | 
| Incidence rate of PML in confirmed PML in US adult de novo Epstein Barr Virus (EBV)-seropositive kidney transplant recipients treated with Nulojix (belatacept) in clinical practice |  | Every 6 months for up to 72 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic, clinical and treatment characteristics of patients receiving Nulojix (belatacept) |  | Every 6 months for up to 72 months | 
| Rates of graft survival observed in the Nulojix (belatacept) treated patients |  | Every 6 months for up to 72 months | 
| Rates of patient survival observed in the Nulojix (belatacept) treated patients |  | Every 6 months for up to 72 months | 
| Incidence rate of confirmed PTLD and confirmed CNS PTLD by baseline CMV serostatus among Nulojix (belatacept) treated population |  | Every 6 months for up to 72 months | 
| Incidence rates of total reported PTLD, reported CNS PTLD and reported PML in adult de novo EBV seropositive kidney transplant recipients treated with Nulojix (belatacept) |  | Every 6 months for up to 72 months | 
| Incidence rates of total reported PTLD and of total reported CNS PTLD by baseline CMV serostatus among Nulojix (belatacept) treated patients |  | Every 6 months for up to 72 months |