Kidney Transplantation: Transplantation, Kidney
Conditions
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The prevalence of Belatacept use | Up to 72 months | Timeframe: Every 6 months 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 | Up to 72 months | EBV = Epstein-Barr virus; CMV = cytomegalovirus; Timeframe: Every 6 months 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 | Up to 72 months | Characteristics of adult kidney-only transplant recipients assessed are age, sex, ethnicity, EBV serostatus, CMV serostatus, organ characteristics, concomitant immunosuppressive medication use, and type of induction medication use. CNI = calcineurin inhibitors; Timeframe: Every 6 months up to 72 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Temporal trend in switches during 7 years post-approval | 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 | Every 6 months up to 72 months | — |
| 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 | Every 6 months up to 72 months | Characteristics of adult, EBV seropositive, kidney-only transplant recipients assessed are age, sex, ethnicity, CMV serostatus, organ characteristics, concomitant immunosuppressive medication use, and type of induction medication use |
| 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 | 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 | 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 | 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) | Every 6 months up to 72 months | — |
Outcome results
None listed