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

This study is currently recruiting participants.
Verified May 2012 by Bristol-Myers Squibb
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01386359
First received: June 28, 2011
Last updated: May 29, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Kidney Transplantation
 Drug: No Intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Evaluating Nulojix Long-Term Safety in Transplant

Resource links provided by NLM:

Drug Information available for: Belatacept
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Demographic, clinical and treatment characteristics of patients receiving Nulojix (belatacept) [ Time Frame: Every 6 months for up to 72 months ] [ Designated as safety issue: No ]
  • Rates of graft survival observed in the Nulojix (belatacept) treated patients [ Time Frame: Every 6 months for up to 72 months ] [ Designated as safety issue: Yes ]
  • Rates of patient survival observed in the Nulojix (belatacept) treated patients [ Time Frame: Every 6 months for up to 72 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3500
Study Start Date: February 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All adult de novo EBV-seropositive kidney transplant recipients

Criteria

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 Nulojix (belatacept) under a clinical trial protocol only
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386359

Contacts
Contact: For participation information at a USA site use a phone number below. For Site information outside USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

Locations
United States, Georgia
Emory Healthcare - Emory University Hospital (EUH) Recruiting
Atlanta, Georgia, United States, 30322
Contact: Christian Larsen, Site B0001     404-712-7168        
Sponsors and Collaborators
Bristol-Myers Squibb
Parexel
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01386359     History of Changes
Other Study ID Numbers: IM103-076
Study First Received: June 28, 2011
Last Updated: May 29, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013