Kidney TransplantationENLISTNCT01386359
Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant
An observational study of Kidney Transplantation, run by Bristol-Myers Squibb at 36 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- How many people
- 914 participants
- Where
- 36 sitesUnited States
- Study dates
- 29 Feb 2012to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult de novo EBV-seropositive kidney transplant recipients
Who may be able to join
- Adult kidney transplant recipient (age ≥18 years at time of transplant)
- Kidney-only transplant recipient
- Positive EBV serostatus
- 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)
Who cannot join
- 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
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Emory Healthcare - Emory University Hospital (EUH)
Atlanta, Georgia, 30322
University of Colorado School of Medicine
Aurora, Colorado, 80045
University of Maryland Medical Center
Baltimore, Maryland, 21201
Medical University of South Carolina
Charleston, South Carolina, 29425
Carolinas Medical Center
Charlotte, North Carolina, 28203
Univ of Virginia HSC
Charlottesville, Virginia, 22908
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Illinois Mecial Center
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
The Christ Hospital Cancer Research
Cincinnati, Ohio, 45219
UT Southwestern Medical Center
Dallas, Texas, 75390
Denver Nephrologists
Denver, Colorado, 80218
The Iowa Clinic
Des Moines, Iowa, 50309
St. Clair Nephrology Research
Detroit, Michigan, 48236
Bms Clinical Research Center
Does Not Exist, New Jersey, 08690-3542
Lutheran Kidney Transplant Center
Fort Wayne, Indiana, 46804
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of California, Los Angeles
Los Angeles, California, 90024
USC University Hospital
Los Angeles, California, 90033
Cedars-Sinai Med Center
Los Angeles, California, 90048
St. Vincent Medical Center - Los Angeles
Los Angeles, California, 90057
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Yale University (Yale New Haven Hospital)
New Haven, Connecticut, 06510
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
New York- Presbyterian/ Weill Cornell Medical Canter
New York, New York, 10065
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Maine Medical Center
Portland, Maine, 04102
California Institute of Renal Research
San Diego, California, 92123
University of California San Francisco Medical Center
San Francisco, California, 94143
Swedish Medical Center
Seattle, Washington, 98104
Baystate Medical Center
Springfield, Massachusetts, 01107
Barnes-Jewish Hospital
St Louis, Missouri, 63100
Tampa General Hospital
Tampa, Florida, 33606
University of Arizona
Tucson, Arizona, 85724
About this study
Official title: 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.
Read the 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
- Conditions
- Kidney Transplantation
- Being tested
- No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionDrug
No Intervention. Subjects are previously treated with Nulojix (belatacept)
| Study group | Role | What they receive |
|---|---|---|
| Adult de novo EBV-seropositive kidney-transplant recipients | Adult de novo EBV-seropositive kidney-transplant recipients treated with Nulojix (belatacept) Receives: Drug: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Every 6 months for up to 72 months
Secondary outcomes (6)
Demographic, clinical and treatment characteristics of patients receiving Nulojix (belatacept)
Measured: Every 6 months for up to 72 months
Rates of graft survival observed in the Nulojix (belatacept) treated patients
Measured: Every 6 months for up to 72 months
Rates of patient survival observed in the Nulojix (belatacept) treated patients
Measured: 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
Measured: 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)
Measured: 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
Measured: Every 6 months for up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study start29 Feb 2012
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 914 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386359
- Sponsor's protocol ID
- IM103-076
- Acronym
- ENLIST
- Status last verified
- May 2022
- First submitted
- 28 Jun 2011
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Nulojix Long-Term Safety in Transplant
- ClinicalTrials.gov ID
- NCT01386359
- Acronym / sponsor ID
- ENLIST / IM103-076
- Conditions
- Kidney Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 914 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 29 Feb 2012 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 1 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult de novo EBV-seropositive kidney-transplant recipients | – | Drug: No InterventionAdult de novo EBV-seropositive kidney-transplant recipients treated with Nulojix (belatacept) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult de novo EBV-seropositive kidney transplant recipients
Key inclusion criteria (6 listed)
- Adult kidney transplant recipient (age ≥18 years at time of transplant)
- Kidney-only transplant recipient
- Positive EBV serostatus
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention. Subjects are previously treated with Nulojix (belatacept) | Drug | Adult de novo EBV-seropositive kidney-transplant recipients |
Primary outcome
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
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
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
6 secondary outcomes
Demographic, clinical and treatment characteristics of patients receiving Nulojix (belatacept)
Time frame: 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
Rates of patient survival observed in the Nulojix (belatacept) treated patients
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by Bristol-Myers Squibb at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.