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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplantation

Phase: N/A

Status: Active, not recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Clinical Details

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

Study design: Observational Model: Cohort

Primary outcome:

Incidences of Post-transplant Lymphoproliferative Disorder (PTLD)

Incidences of hospitalized infections

Incidences of malignancy

Secondary outcome:

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

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

Cumulative incidence of hospitalized infections in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation

Incidence rates of graft rejection in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation

Incidence rates of graft failure in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation

Mortality rate of composite bacterial, fungal, viral, tuberculosis, herpes, and CMV infections

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: March 2012
Last updated: August 11, 2015

Page last updated: August 23, 2015

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