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Belatacept and Risk of Post-transplant Lymphoproliferative Disorder in US Renal Transplant Recipients

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; Transplantation, Kidney

Intervention: Calcineurin inhibitors (CNI) (Drug); Belatacept (Drug)

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

- To estimate the incidence rates of post-transplant lymphoproliferative disorder (PTLD)

in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept at the time of transplantation

- To estimate the incidence rates of PTLD in adult, EBV seropositive, kidney alone

transplant recipients treated with calcineurin inhibitors (CNI)-based regimens at the time of transplantation

- To compare the PTLD incidence rates in adult, EBV seropositive, kidney alone transplant

recipients treated with belatacept to the rates in adult, EBV seropositive, kidney alone transplant recipients treated with CNI-based regimens at the time of transplantation

Clinical Details

Official title: Belatacept and Risk of PTLD in US Renal Transplant Recipients

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome:

Incidence rates of post-transplant lymphoproliferative disorder (PTLD) in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept at the time of transplantation

Incidence rates of PTLD in adult, EBV seropositive, kidney alone transplant recipients treated with calcineurin inhibitors (CNI)-based regimens at the time of transplantation

Ratio for PTLD incidence rates in adult, EBV seropositive, kidney alone, belatacept treated patients and adult EBV seropositive, kidney alone, CNI-treated patients at the time of transplantation

Secondary outcome:

Incidence rates of PTLD in subgroups of belatacept-treated, adult, kidney alone transplant recipients defined by recipient Epstein-Barr virus (EBV) serostatus (negative or unknown) and by donor to recipient EBV serostatus

Ratio for PTLD incidence rates in the belatacept-treated subgroups defined by EBV serostatus (negative or unknown) to the rates in corresponding CNI-treated subgroups

Incidence rates of PTLD in subgroups of belatacept-treated, adult, kidney alone transplant recipients defined by recipient cytomegalovirus (CMV) serostatus and by donor to recipient CMV serostatus

Ratio for PTLD incidence rates in the belatacept-treated subgroups defined by CMV serostatus to the rates in corresponding CNI-treated subgroups

Characteristics (age, gender, weight, BMI, use of immunosuppressive medications, and type of induction medications) of PTLD cases, and the location and mortality of PTLD

Ratio for characteristics of PTLD cases, and the location and mortality of PTLD, in adult, kidney alone transplant recipients treated with belatacept at transplantation to those treated with CNI-based regimens at transplantation

Two year incidence rates of PTLD by calendar year of transplantation in adult, kidney alone transplant recipients treated with belatacept at transplantation, and in subgroups of these transplant recipients defined by EBV serostatus and by CMV serostatus

Incidence rates of PTLD by immunosuppressive regimen changes in adult, kidney alone transplant recipients who switch to or from belatacept during the period from transplant to the end of one-year follow-up

Eligibility

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

Criteria:

For more information regarding BMS clinical trial participation, please visit www. BMSStudyConnect. com. Inclusion Criteria:

- Adult,

- EBV seropositive, Kidney only transplant recipients initiated on belatacept and

adult,

- EBV seropositive, kidney only transplant recipients initiated on CNIs reported to the

United Network for Organ Sharing (UNOS) during the period of recruiting belatacept users

Locations and Contacts

Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: June 2011
Last updated: August 11, 2015

Page last updated: August 23, 2015

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