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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult de novo EBV-seropositive kidney-transplant recipients | Adult de novo EBV-seropositive kidney-transplant recipients treated with Nulojix (belatacept) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Drug | No Intervention. Subjects are previously treated with Nulojix (belatacept) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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All adult de novo EBV-seropositive kidney transplant recipients
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | United States | ||
| University of California, Los Angeles |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| 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 |
| Los Angeles |
| California |
| 90024 |
| United States |
| USC University Hospital | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Med Center | Los Angeles | California | 90048 | United States |
| St. Vincent Medical Center - Los Angeles | Los Angeles | California | 90057 | United States |
| California Institute of Renal Research | San Diego | California | 92123 | United States |
| University of California San Francisco Medical Center | San Francisco | California | 94143 | United States |
| University of Colorado School of Medicine | Aurora | Colorado | 80045 | United States |
| Denver Nephrologists | Denver | Colorado | 80218 | United States |
| Yale University (Yale New Haven Hospital) | New Haven | Connecticut | 06510 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Emory Healthcare - Emory University Hospital (EUH) | Atlanta | Georgia | 30322 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| University of Illinois Mecial Center | Chicago | Illinois | 60612 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Lutheran Kidney Transplant Center | Fort Wayne | Indiana | 46804 | United States |
| The Iowa Clinic | Des Moines | Iowa | 50309 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01107 | United States |
| St. Clair Nephrology Research | Detroit | Michigan | 48236 | United States |
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63100 | United States |
| Bms Clinical Research Center | Does Not Exist | New Jersey | 08690-3542 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| New York- Presbyterian/ Weill Cornell Medical Canter | New York | New York | 10065 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| The Christ Hospital Cancer Research | Cincinnati | Ohio | 45219 | United States |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Univ of Virginia HSC | Charlottesville | Virginia | 22908 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |