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EVALUATING NULOJIX LONG TERM SAFETY IN TRANSPLANT ENLiST REGISTRY

Description

Chronic kidney disease (CKD) affects a large proportion of the United States population;in 2008 there were approximately 15.8 million patients with CKD. Kidney transplant is the treatment of choice for patients with ESRD. The introduction of immunosuppressive agents has greatly improved short-term allograft survival, and renal transplant patients are surviving longer. There are a variety of different immunosuppressive regimens that are utilized.This study is a prospective voluntary multi-center registry with a purpose to determine the incidence rate of confirmed PTLD, CNS PTLD and PML in the adult kidney transplant recipients, regardless of EBV serostatus, who receive belatacept following a kidney transplant (de novo) and those who switch to belatacept after other therapies. Subjects who are enrolled to the study will be followed for a minimum of two years.All data will be submitted to the sponsor who will perform the statistical analysis of the data.

Phase

Other

Inclusion 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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