Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant
- Registration Number
- NCT01386359
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 914
-
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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adult de novo EBV-seropositive kidney-transplant recipients No Intervention Adult de novo EBV-seropositive kidney-transplant recipients treated with Nulojix (belatacept)
- Primary Outcome Measures
Name Time Method 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 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 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 Every 6 months for up to 72 months
- Secondary Outcome Measures
Name Time Method Demographic, clinical and treatment characteristics of patients receiving Nulojix (belatacept) Every 6 months for up to 72 months Rates of graft survival observed in the Nulojix (belatacept) treated patients Every 6 months for up to 72 months Rates of patient survival observed in the Nulojix (belatacept) treated patients 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 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) 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 Every 6 months for up to 72 months
Trial Locations
- Locations (36)
University of Arizona
🇺🇸Tucson, Arizona, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
USC University Hospital
🇺🇸Los Angeles, California, United States
Cedars-Sinai Med Center
🇺🇸Los Angeles, California, United States
St. Vincent Medical Center - Los Angeles
🇺🇸Los Angeles, California, United States
California Institute of Renal Research
🇺🇸San Diego, California, United States
University of California San Francisco Medical Center
🇺🇸San Francisco, California, United States
University of Colorado School of Medicine
🇺🇸Aurora, Colorado, United States
Denver Nephrologists
🇺🇸Denver, Colorado, United States
Yale University (Yale New Haven Hospital)
🇺🇸New Haven, Connecticut, United States
Scroll for more (26 remaining)University of Arizona🇺🇸Tucson, Arizona, United States