Clinical trial NCT01670058: Pattern Of Use Of Belatacept In US Transplant Recipients
Official title: Pattern Of Use Of Belatacept In US Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation: Transplantation, Kidney
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-08-21
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort for the analyses of all transplants includes all organ transplant recipients who are reported with Belatacept at transplant

Brief 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.


Eligibility 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:

Primary outcomes:
measure: The prevalence of Belatacept use
timeFrame: Up to 72 months
measure: Characteristics 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
timeFrame: Up to 72 months
measure: 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
timeFrame: Up to 72 months
Secondary outcomes:
measure: 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 Belatacept
timeFrame: Every 6 months up to 72 months
measure: Extent of switches to or from Belatacept within one year post-transplant in adult, kidney-only transplant recipients
timeFrame: Every 6 months up to 72 months
measure: 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)
timeFrame: Every 6 months up to 72 months
measure: Temporal trend in switches during 7 years post-approval
timeFrame: Every 6 months up to 72 months
measure: 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
timeFrame: Every 6 months up to 72 months
measure: 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
timeFrame: Every 6 months up to 72 months
measure: 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
timeFrame: Every 6 months up to 72 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: