Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant
NCT ID: NCT01386359
Last Updated: 2022-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
914 participants
OBSERVATIONAL
2012-02-29
2019-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Adult de novo EBV-seropositive kidney-transplant recipients
Adult de novo EBV-seropositive kidney-transplant recipients treated with Nulojix (belatacept)
No Intervention
No Intervention. Subjects are previously treated with Nulojix (belatacept)
Interventions
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No Intervention
No Intervention. Subjects are previously treated with Nulojix (belatacept)
Eligibility Criteria
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Inclusion Criteria
* 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
* \<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
18 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Columbia University Medical Center
New York, New York, United States
New York- Presbyterian/ Weill Cornell Medical Canter
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
The Christ Hospital Cancer Research
Cincinnati, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Univ of Virginia HSC
Charlottesville, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Related Links
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BMS Clinical Trial Information
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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IM103-076
Identifier Type: -
Identifier Source: org_study_id
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