Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study

Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study (CTS)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01471223

Acronym

CTS

Enrollment

Registered

2011-11-15

Start date

2012-03-31

Completion date

2017-08-08

Last updated

2017-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidences of Post-transplant Lymphoproliferative Disorder (PTLD)	5 years post transplantation
Incidences of hospitalized infections	2 years post transplantation
Incidences of malignancy	5 years post transplantation

Secondary

Measure	Time frame	Description
Incidence rates of graft rejection in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation	Every 6 months and 12 months	—
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	Every 6 months and 12 months	—
Mortality rate of composite bacterial, fungal, viral, tuberculosis, herpes, and CMV infections	2 years post transplantation	—
Incidence rates of graft failure in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation	Every 6 months and 12 months	—
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	Every 6 months and 12 months	Subgroups of the transplant recipients defined by donor-recipient EBV serostatus at the time of transplantation
Cumulative incidence of hospitalized infections in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation	Every 6 months and 12 months	Hospitalized infections for the following infection groups: 1. Bacterial 2. fungal 3. Viral 4. Tuberculosis 5. Herpes and 6. Cytomegalovirus (CMV)

Outcome results