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

June 2, 2022 updated by: Bristol-Myers Squibb

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
914

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Every 6 months for up to 72 months
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
Time Frame: Every 6 months for up to 72 months
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
Time Frame: Every 6 months for up to 72 months
Every 6 months for up to 72 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Demographic, clinical and treatment characteristics of patients receiving Nulojix (belatacept)
Time Frame: Every 6 months for up to 72 months
Every 6 months for up to 72 months
Rates of graft survival observed in the Nulojix (belatacept) treated patients
Time Frame: Every 6 months for up to 72 months
Every 6 months for up to 72 months
Rates of patient survival observed in the Nulojix (belatacept) treated patients
Time Frame: Every 6 months for up to 72 months
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
Time Frame: Every 6 months for up to 72 months
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)
Time Frame: Every 6 months for up to 72 months
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
Time Frame: Every 6 months for up to 72 months
Every 6 months for up to 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Parexel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 29, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM103-076

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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