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

Kidney Transplantation Clinical Trial

— CTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471223
• Other study ID #: IM103-089
• Status: Completed
• Phase: N/A
• First received: November 10, 2011
• Last updated: September 18, 2017
• Start date: March 31, 2012
• Est. completion date: August 8, 2017

Study information

• Verified date: September 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Time Perspective: Prospective design, Retrospective data collection and analysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 8, 2017
• Est. primary completion date: August 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Heidelberg University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidences of Post-transplant Lymphoproliferative Disorder (PTLD)		5 years post transplantation
Primary	Incidences of hospitalized infections		2 years post transplantation
Primary	Incidences of malignancy		5 years post transplantation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mortality rate of composite bacterial, fungal, viral, tuberculosis, herpes, and CMV infections		2 years post transplantation

External Links

•   BMS Clinical Trials Disclosure
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