Pattern Of Use Of Belatacept In US Transplant Recipients
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: Transplantation, Kidney
Phase: N/A
Status: Active, not recruiting
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s): Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Summary
- The prevalence of Belatacept use
- The characteristics of Belatacept users and the temporal trends in these
characteristics
- Characteristics of adult kidney-only transplant recipients who are treated with
Belatacept vs. who are treated with Calcineurin inhibitors (CNI)-based regimens at the
time of transplantation, and the temporal trends in these characteristics during 7
years post approval of Belatacept.
Clinical Details
Official title: Pattern Of Use Of Belatacept In US Transplant Recipients
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: The prevalence of Belatacept useCharacteristics of Belatacept users, in terms of age, sex, ethnicity, transplanted organs, donor EBV infection-recipient EBV serostatus, donor CMV infection-recipient CMV serostatus, and the temporal trends in these characteristics Characteristics of adult kidney-only transplant recipients who are treated with Belatacept vs. who are treated with CNI-based regimens at the time of transplantation and temporal trends in these characteristics during 7 years post approval of Belatacept
Secondary outcome: Characteristics of adult EBV seropositive kidney-only transplant recipients treated with Belatacept vs who are treated with CNI-based regimens at time of transplantation & temporal trends in these characteristics during 7 yrs post approval of BelataceptExtent of switches to or from Belatacept within one year post-transplant in adult, kidney-only transplant recipients Characteristics of switchers vs. non-switchers (age, sex, ethnicity, EBV serostatus, CMV serostatus, organ characteristics, concomitant immunosuppressive medication use, and type of induction medication use) Temporal trend in switches during 7 years post-approval CMV treatment/prophylaxis by CMV serostatus in adult kidney-only transplant recipients who had anti-CMV therapy data recorded in United Network for Organ Sharing (UNOS) and treated with Belatacept vs. CNIs at transplantation CMV treatment/prophylaxis by CMV serostatus in adult kidney-only transplant recipients who had anti-CMV therapy data recorded in UNOS and switched to Belatacept, switched from Belatacept, or did not switch Characteristics of Belatacept users stratified by EBV serostatus, including age, sex, ethnicity, general medical factors, transplant history (organ, date, graft failure date), and donor organ characteristics
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
For more information regarding BMS clinical trial participation, please visit
www. BMSStudyConnect. com.
Inclusion Criteria:
- The cohort for the analyses of all transplants includes all organ transplant
recipients who are reported with Belatacept at transplant
Exclusion Criteria:
Locations and Contacts
Additional Information
BMS Clinical Trials Disclosure Investigator Inquiry form FDA Safety Alerts and Recalls
Starting date: January 2012
Last updated: August 11, 2015
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