Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant

Completed

Conditions studied: Kidney Transplantation

In brief

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.

Key facts

Study ID

NCT01386359

Run by

Bristol-Myers Squibb

People needed

914

Starts

2012-02-29

Expected to finish

2019-04-30

Last updated by the study team

2022-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Arizona — Tucson, Arizona, United States
• University of California, Los Angeles — Los Angeles, California, United States
• USC University Hospital — Los Angeles, California, United States
• Cedars-Sinai Med Center — Los Angeles, California, United States
• St. Vincent Medical Center - Los Angeles — Los Angeles, California, United States
• California Institute of Renal Research — San Diego, California, United States
• University of California San Francisco Medical Center — San Francisco, California, United States
• University of Colorado School of Medicine — Aurora, Colorado, United States
• Denver Nephrologists — Denver, Colorado, United States
• Yale University (Yale New Haven Hospital) — New Haven, Connecticut, United States
• Tampa General Hospital — Tampa, Florida, United States
• Emory Healthcare - Emory University Hospital (EUH) — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Illinois Mecial Center — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Lutheran Kidney Transplant Center — Fort Wayne, Indiana, United States
• The Iowa Clinic — Des Moines, Iowa, United States
• Maine Medical Center — Portland, Maine, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• St. Clair Nephrology Research — Detroit, Michigan, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Bms Clinical Research Center — Does Not Exist, New Jersey, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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