Clinical trial NCT01386359: Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant
Official title: Evaluating Nulojix Long-Term Safety in Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2011-07-01
Enrollment: 914
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult de novo EBV-seropositive kidney transplant recipients

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Every 6 months for up to 72 months
measure: 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
timeFrame: Every 6 months for up to 72 months
measure: 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
timeFrame: Every 6 months for up to 72 months
Secondary outcomes:
measure: Demographic, clinical and treatment characteristics of patients receiving Nulojix (belatacept)
timeFrame: Every 6 months for up to 72 months
measure: Rates of graft survival observed in the Nulojix (belatacept) treated patients
timeFrame: Every 6 months for up to 72 months
measure: Rates of patient survival observed in the Nulojix (belatacept) treated patients
timeFrame: Every 6 months for up to 72 months
measure: Incidence rate of confirmed PTLD and confirmed CNS PTLD by baseline CMV serostatus among Nulojix (belatacept) treated population
timeFrame: Every 6 months for up to 72 months
measure: 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)
timeFrame: Every 6 months for up to 72 months
measure: Incidence rates of total reported PTLD and of total reported CNS PTLD by baseline CMV serostatus among Nulojix (belatacept) treated patients
timeFrame: Every 6 months for up to 72 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Med Center
state: California
city: Los Angeles
country: United States
facility: St. Vincent Medical Center - Los Angeles
state: California
city: San Diego
country: United States
facility: California Institute of Renal Research
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Denver
country: United States
facility: Denver Nephrologists
state: Colorado
city: New Haven
country: United States
facility: Yale University (Yale New Haven Hospital)
state: Connecticut
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory Healthcare - Emory University Hospital (EUH)
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Mecial Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Lutheran Kidney Transplant Center
state: Indiana
city: Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: St. Clair Nephrology Research
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Does Not Exist
country: United States
facility: Bms Clinical Research Center
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: New York- Presbyterian/ Weill Cornell Medical Canter
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital Cancer Research
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Charlottesville
country: United States
facility: Univ of Virginia HSC
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: