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

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation

Detailed Description

Time Perspective: Prospective design, Retrospective data collection and analysis

• Study Type: Observational
• Enrollment (Actual): 89

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients receiving Belatacept in CTS; Patients receiving a 1st kidney-only transplant at a center participating in the CTS and receiving Belatacept at the time of transplantation
Patients receiving CNI in CTS; Patients receiving a 1st kidney-only transplant at a center participating in the CTS and receiving CNI at the time of transplantation

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	Subgroups of the transplant recipients defined by donor-recipient EBV serostatus at the time of transplantation	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	Hospitalized infections for the following infection groups: Bacterial; fungal; Viral; Tuberculosis; Herpes and; Cytomegalovirus (CMV)	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		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		Every 6 months and 12 months
Mortality rate of composite bacterial, fungal, viral, tuberculosis, herpes, and CMV infections		2 years post transplantation

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Heidelberg University

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls
• BMS Clinical Trials Disclosure

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2012
• Primary Completion (Actual): August 8, 2017
• Study Completion (Actual): August 8, 2017

Study Registration Dates

• First Submitted: November 10, 2011
• First Submitted That Met QC Criteria: November 14, 2011
• First Posted (Estimate): November 15, 2011

Study Record Updates

• Last Update Posted (Actual): September 19, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IM103-089