Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant

Kidney Transplantation Clinical Trial

— ENLIST  

Official title:

Evaluating Nulojix Long-Term Safety in Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01386359
• Other study ID #: IM103-076
• Status: Completed
• Start date: February 29, 2012
• Est. completion date: April 30, 2019

Study information

• Verified date: May 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 914
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

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

Locations

Country	Name	City	State
United States	Emory Healthcare - Emory University Hospital (EUH)	Atlanta	Georgia
United States	University of Colorado School of Medicine	Aurora	Colorado
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Univ of Virginia HSC	Charlottesville	Virginia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Illinois Mecial Center	Chicago	Illinois
United States	The Christ Hospital Cancer Research	Cincinnati	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Denver Nephrologists	Denver	Colorado
United States	The Iowa Clinic	Des Moines	Iowa
United States	St. Clair Nephrology Research	Detroit	Michigan
United States	Bms Clinical Research Center	Does Not Exist	New Jersey
United States	Lutheran Kidney Transplant Center	Fort Wayne	Indiana
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Cedars-Sinai Med Center	Los Angeles	California
United States	St. Vincent Medical Center - Los Angeles	Los Angeles	California
United States	University of California, Los Angeles	Los Angeles	California
United States	USC University Hospital	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Yale University (Yale New Haven Hospital)	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	New York- Presbyterian/ Weill Cornell Medical Canter	New York	New York
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	Maine Medical Center	Portland	Maine
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	California Institute of Renal Research	San Diego	California
United States	University of California San Francisco Medical Center	San Francisco	California
United States	Swedish Medical Center	Seattle	Washington
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Tampa General Hospital	Tampa	Florida
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Parexel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Demographic, clinical and treatment characteristics of patients receiving Nulojix (belatacept)		Every 6 months for up to 72 months
Secondary	Rates of graft survival observed in the Nulojix (belatacept) treated patients		Every 6 months for up to 72 months
Secondary	Rates of patient survival observed in the Nulojix (belatacept) treated patients		Every 6 months for up to 72 months
Secondary	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
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls