Clinical trial NCT01471223: Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study
Official title: Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study (CTS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Heidelberg University
First posted: 2011-11-15
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing 1st kidney only transplantation, whose transplant centers participate in CTS and who are treated with Belatacept or a CNI based regimen at the time of transplantation

Brief summary: The purpose of the study is to estimate the incidence rates of Post-transplant Lymphoproliferative Disorder (PTLD), malignancy and hospitalized infections in adult kidney-only transplant recipients treated with Belatacept, and compared the incidences to the incidences in those treated with Calcineurin inhibitor (CNI) based regimens at the time of transplantation.

Detailed description: Time Perspective: Prospective design, Retrospective data collection and analysis

Eligibility criteria: Inclusion Criteria:

* 1st kidney only transplant during study, at one of the transplant centers participating in CTS, received Belatacept or a CNI at the time of transplantation

Exclusion Criteria:

* Patients with a history of malignancy

Primary outcomes:
measure: Incidences of Post-transplant Lymphoproliferative Disorder (PTLD)
timeFrame: 5 years post transplantation
measure: Incidences of hospitalized infections
timeFrame: 2 years post transplantation
measure: Incidences of malignancy
timeFrame: 5 years post transplantation
Secondary outcomes:
measure: Incidence rates of PTLD in adult subgroups of Belatacept- vs. CNI-treated, kidney-only transplant recipients defined by donor-recipient Epstein Barr virus (EBV) serostatus and by age groups
timeFrame: Every 6 months and 12 months
measure: Location, mortality, and tumor type of all PTLD cases in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation and in subgroups of these transplant recipients
timeFrame: Every 6 months and 12 months
measure: Cumulative incidence of hospitalized infections in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation
timeFrame: Every 6 months and 12 months
measure: Incidence rates of graft rejection in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation
timeFrame: Every 6 months and 12 months
measure: Incidence rates of graft failure in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation
timeFrame: Every 6 months and 12 months
measure: Mortality rate of composite bacterial, fungal, viral, tuberculosis, herpes, and CMV infections
timeFrame: 2 years post transplantation
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: