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Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplantation

Intervention: No Intervention (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Overall contact:
For participation information at a USA site use a phone number below. For Site information outside USA please email:, Email: Clinical.Trials@bms.com

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.

Clinical Details

Official title: Evaluating Nulojix Long-Term Safety in Transplant

Study design: Observational Model: Cohort

Primary outcome:

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

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

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

Secondary outcome:

Demographic, clinical and treatment characteristics of patients receiving Nulojix (belatacept)

Rates of graft survival observed in the Nulojix (belatacept) treated patients

Rates of patient survival observed in the Nulojix (belatacept) treated patients

Incidence rate of confirmed PTLD and confirmed CNS PTLD by baseline CMV serostatus among Nulojix (belatacept) treated population

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)

Incidence rates of total reported PTLD and of total reported CNS PTLD by baseline CMV serostatus among Nulojix (belatacept) treated patients

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

For more information regarding BMS clinical trial participation, please visit www. BMSStudyConnect. com. 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 Nulojix (belatacept) under a clinical trial protocol only

- 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

Locations and Contacts

For participation information at a USA site use a phone number below. For Site information outside USA please email:, Email: Clinical.Trials@bms.com

Emory Healthcare - Emory University Hospital (EUH), Atlanta, Georgia 30322, United States; Recruiting
Christian Larsen, Site B0001, Phone: 404-712-7168
Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link

Starting date: February 2012
Last updated: August 11, 2015

Page last updated: August 23, 2015

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