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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

Evaluating Nulojix Long-Term Safety in Transplant

Details

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

Keywords

Kidney Transplantation Abatacept

Eligibility

For people ages 18 years and up

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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

Locations

  • University of California, Los Angeles
    Los Angeles, California, 90024, United States
  • Cedars-Sinai Med Center
    Los Angeles, California, 90048, United States
  • St. Vincent Medical Center - Los Angeles
    Los Angeles, California, 90057, United States
  • USC University Hospital
    Los Angeles, California, 90033, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trials Disclosure
Investigator Inquiry form
For FDA Safety Alerts and Recalls refer to the following link
ID
NCT01386359
Study Type
Observational
Last Updated
August 1, 2017