Brief Summary

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Official Title: "Pattern Of Use Of Belatacept In US Transplant Recipients"

- 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort, Time Perspective: Retrospective
• Study Primary Completion Date: January 2017

Arms, Groups and Cohorts in this Clinical Trial

• Belatacept treated adult kidney-only transplant recipients
  • All adult kidney-only transplant recipients treated with Nulojix (Belatacept)
• CNIs at transplantation

Outcome Measures for this Clinical Trial

Primary Measures

• The prevalence of Belatacept use
  • Time Frame: Up to 72 months
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• Temporal trend in switches during 7 years post-approval
  • Time Frame: Every 6 months up to 72 months
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• The cohort for the analyses of all transplants includes all organ transplant recipients who are reported with Belatacept at transplant

Exclusion Criteria

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Bristol-Myers Squibb
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb