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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 use

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

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 Belatacept

Extent 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

Page last updated: August 23, 2015

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