An observational study in Kidney Transplantation, sponsored by Bristol-Myers Squibb. Completed at 36 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-06.
Sponsored by Bristol-Myers Squibb · Observational
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.
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
Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
All adult de novo EBV-seropositive kidney transplant recipients
Positive EBV serostatus
a) EBV serostatus negative or unknown included per the investigator discretion
Exclusion Criteria:
Adult de novo EBV-seropositive kidney-transplant recipients treated with Nulojix (belatacept)
Drug: No Intervention
No Intervention. Subjects are previously treated with Nulojix (belatacept)
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
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
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb