Overview

This trial is active, not recruiting.

Condition kidney transplantation
Sponsor Bristol-Myers Squibb
Collaborator Heidelberg University
Start date March 2012
End date April 2018
Trial size 5000 participants
Trial identifier NCT01471223, IM103-089

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Arm
Patients receiving a 1st kidney-only transplant at a center participating in the CTS and receiving Belatacept at the time of transplantation
Patients receiving a 1st kidney-only transplant at a center participating in the CTS and receiving CNI at the time of transplantation

Primary Outcomes

Measure
Incidences of Post-transplant Lymphoproliferative Disorder (PTLD)
time frame: 5 years post transplantation
Incidences of hospitalized infections
time frame: 2 years post transplantation
Incidences of malignancy
time frame: 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
time frame: 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
time frame: Every 6 months and 12 months
Cumulative incidence of hospitalized infections in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation
time frame: Every 6 months and 12 months
Incidence rates of graft rejection in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation
time frame: Every 6 months and 12 months
Incidence rates of graft failure in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation
time frame: Every 6 months and 12 months
Mortality rate of composite bacterial, fungal, viral, tuberculosis, herpes, and CMV infections
time frame: 2 years post transplantation

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study (CTS)
Description Time Perspective: Prospective design, Retrospective data collection and analysis
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.