Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant
ENLIST
Evaluating Nulojix Long-Term Safety in Transplant
1 other identifier
observational
914
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2012
Longer than P75 for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2011
CompletedFirst Posted
Study publicly available on registry
July 1, 2011
CompletedStudy Start
First participant enrolled
February 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedJune 6, 2022
May 1, 2022
7.2 years
June 28, 2011
June 2, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Incidence rate of confirmed PTLD in US adult de novo Epstein Barr Virus (EBV)-seropositive kidney transplant recipients treated with Nulojix (belatacept) in clinical practice
Every 6 months for up to 72 months
Incidence rate of confirmed CNS PTLD in US adult de novo Epstein Barr Virus (EBV)-seropositive kidney transplant recipients treated with Nulojix (belatacept) in clinical practice
Every 6 months for up to 72 months
Incidence rate of PML in confirmed PML in US adult de novo Epstein Barr Virus (EBV)-seropositive kidney transplant recipients treated with Nulojix (belatacept) in clinical practice
Every 6 months for up to 72 months
Secondary Outcomes (6)
Demographic, clinical and treatment characteristics of patients receiving Nulojix (belatacept)
Every 6 months for up to 72 months
Rates of graft survival observed in the Nulojix (belatacept) treated patients
Every 6 months for up to 72 months
Rates of patient survival observed in the Nulojix (belatacept) treated patients
Every 6 months for up to 72 months
Incidence rate of confirmed PTLD and confirmed CNS PTLD by baseline CMV serostatus among Nulojix (belatacept) treated population
Every 6 months for up to 72 months
Incidence rates of total reported PTLD, reported CNS PTLD and reported PML in adult de novo EBV seropositive kidney transplant recipients treated with Nulojix (belatacept)
Every 6 months for up to 72 months
- +1 more secondary outcomes
Study Arms (1)
Adult de novo EBV-seropositive kidney-transplant recipients
Adult de novo EBV-seropositive kidney-transplant recipients treated with Nulojix (belatacept)
Interventions
No Intervention. Subjects are previously treated with Nulojix (belatacept)
Eligibility Criteria
All adult de novo EBV-seropositive kidney transplant recipients
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Parexelcollaborator
Study Sites (36)
University of Arizona
Tucson, Arizona, 85724, United States
University of California, Los Angeles
Los Angeles, California, 90024, United States
USC University Hospital
Los Angeles, California, 90033, United States
Cedars-Sinai Med Center
Los Angeles, California, 90048, United States
St. Vincent Medical Center - Los Angeles
Los Angeles, California, 90057, United States
California Institute of Renal Research
San Diego, California, 92123, United States
University of California San Francisco Medical Center
San Francisco, California, 94143, United States
University of Colorado School of Medicine
Aurora, Colorado, 80045, United States
Denver Nephrologists
Denver, Colorado, 80218, United States
Yale University (Yale New Haven Hospital)
New Haven, Connecticut, 06510, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Emory Healthcare - Emory University Hospital (EUH)
Atlanta, Georgia, 30322, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Illinois Mecial Center
Chicago, Illinois, 60612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Lutheran Kidney Transplant Center
Fort Wayne, Indiana, 46804, United States
The Iowa Clinic
Des Moines, Iowa, 50309, United States
Maine Medical Center
Portland, Maine, 04102, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Baystate Medical Center
Springfield, Massachusetts, 01107, United States
St. Clair Nephrology Research
Detroit, Michigan, 48236, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63100, United States
Bms Clinical Research Center
Does Not Exist, New Jersey, 08690-3542, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
New York- Presbyterian/ Weill Cornell Medical Canter
New York, New York, 10065, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
The Christ Hospital Cancer Research
Cincinnati, Ohio, 45219, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Univ of Virginia HSC
Charlottesville, Virginia, 22908, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Links
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2011
First Posted
July 1, 2011
Study Start
February 29, 2012
Primary Completion
April 30, 2019
Study Completion
April 30, 2019
Last Updated
June 6, 2022
Record last verified: 2022-05