Overview

This trial is active, not recruiting.

Condition kidney transplantation: transplantation, kidney
Sponsor Bristol-Myers Squibb
Start date January 2012
End date June 2017
Trial size 5000 participants
Trial identifier NCT01670058, IM103-074

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
All adult kidney-only transplant recipients treated with Nulojix (Belatacept)

Primary Outcomes

Measure
The prevalence of Belatacept use
time frame: Up to 72 months
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
time frame: Up to 72 months
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
time frame: 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
time frame: Every 6 months up to 72 months
Extent of switches to or from Belatacept within one year post-transplant in adult, kidney-only transplant recipients
time frame: Every 6 months up to 72 months
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)
time frame: Every 6 months up to 72 months
Temporal trend in switches during 7 years post-approval
time frame: Every 6 months up to 72 months
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
time frame: Every 6 months up to 72 months
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
time frame: Every 6 months up to 72 months
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
time frame: Every 6 months up to 72 months

Eligibility Criteria

Male or female participants of any age.

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:

Additional Information

Official title Pattern Of Use Of Belatacept In US Transplant Recipients
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.