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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01386359
First Posted: July 1, 2011
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Parexel
Information provided by (Responsible Party):
Bristol-Myers Squibb
  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
Time Perspective: Other
Official Title: Evaluating Nulojix Long-Term Safety in Transplant

Resource links provided by NLM:


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 ]
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1130
Actual Study Start Date: February 29, 2012
Estimated Study Completion Date: April 30, 2019
Estimated Primary Completion Date: April 30, 2019 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult de novo EBV-seropositive kidney transplant recipients
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386359


  Show 36 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Parexel
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01386359     History of Changes
Other Study ID Numbers: IM103-076
First Submitted: June 28, 2011
First Posted: July 1, 2011
Last Update Posted: August 3, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents


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