Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant (ENLIST)

Evaluating Nulojix Long-Term Safety in Transplant

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation
• Intervention / Treatment: Drug: No Intervention

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 914

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • California
    • Los Angeles, California, United States, 90024
      • University of California, Los Angeles
    • Los Angeles, California, United States, 90033
      • USC University Hospital
    • Los Angeles, California, United States, 90057
      • St. Vincent Medical Center - Los Angeles
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Med Center
    • San Diego, California, United States, 92123
      • California Institute of Renal Research
    • San Francisco, California, United States, 94143
      • University of California San Francisco Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado School of Medicine
    • Denver, Colorado, United States, 80218
      • Denver Nephrologists
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University (Yale New Haven Hospital)
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Healthcare - Emory University Hospital (EUH)
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Chicago, Illinois, United States, 60612
      • University of Illinois Mecial Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Lutheran Kidney Transplant Center
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • The Iowa Clinic
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Massachusetts
    • Springfield, Massachusetts, United States, 01107
      • Baystate Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48236
      • St. Clair Nephrology Research
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63100
      • Barnes-Jewish Hospital
  • New Jersey
    • Does Not Exist, New Jersey, United States, 08690-3542
      • Bms Clinical Research Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10065
      • New York- Presbyterian/ Weill Cornell Medical Canter
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital Cancer Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Baptist Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Univ of Virginia HSC
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult de novo EBV-seropositive kidney transplant recipients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult de novo EBV-seropositive kidney-transplant recipients; Adult de novo EBV-seropositive kidney-transplant recipients treated with Nulojix (belatacept)	Drug: No Intervention; No Intervention. Subjects are previously treated with Nulojix (belatacept)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Incidence rates of total reported PTLD and of total reported CNS PTLD by baseline CMV serostatus among Nulojix (belatacept) treated patients	Every 6 months for up to 72 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Parexel

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2012
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: June 28, 2011
• First Submitted That Met QC Criteria: June 30, 2011
• First Posted (Estimate): July 1, 2011

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IM103-076