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Completed

NCT Number: NCT01386359

Evaluating Nulojix (Belatacept) 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.

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arizona, Tucson, Arizona, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Drug

No Intervention. Subjects are previously treated with Nulojix (belatacept)

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. Demographic, clinical and treatment characteristics of patients receiving Nulojix (belatacept)

    Time frame: Every 6 months for up to 72 months

  2. Rates of graft survival observed in the Nulojix (belatacept) treated patients

    Time frame: Every 6 months for up to 72 months

  3. Rates of patient survival observed in the Nulojix (belatacept) treated patients

    Time frame: Every 6 months for up to 72 months

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Parexel

Registry information

Official study title

Evaluating Nulojix Long-Term Safety in Transplant

Acronym: ENLIST

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Jul 1, 2011
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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