Evaluating Nulojix Long-Term Safety in Transplant
Description
Brief Summary
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
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
Phase
OtherInclusion and Exclusion 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)
- 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
Sites
-
Georgia
- Emory Healthcare - Emory University Hospital (EUH), Atlanta, Georgia, 30322
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