Pattern Of Use Of Belatacept In US Transplant Recipients - Full Text View

Purpose

The prevalence of Belatacept use
The characteristics of Belatacept users and the temporal trends in these characteristics
Characteristics of adult kidney-only transplant recipients who are treated with Belatacept vs. who are treated with Calcineurin inhibitors (CNI)-based regimens at the time of transplantation, and the temporal trends in these characteristics during 7 years post approval of Belatacept.

Condition
Kidney Transplantation: Transplantation, Kidney

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	Pattern Of Use Of Belatacept In US Transplant Recipients

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Belatacept

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

The prevalence of Belatacept use [ Time Frame: Up to 72 months ] [ Designated as safety issue: No ]
Timeframe: Every 6 months up to 72 months
Characteristics of Belatacept users, in terms of age, sex, ethnicity, transplanted organs, donor EBV infection-recipient EBV serostatus, donor CMV infection-recipient CMV serostatus, and the temporal trends in these characteristics [ Time Frame: Up to 72 months ] [ Designated as safety issue: No ]
EBV = Epstein-Barr virus; CMV = cytomegalovirus; Timeframe: Every 6 months up to 72 months
Characteristics of adult kidney-only transplant recipients who are treated with Belatacept vs. who are treated with CNI-based regimens at the time of transplantation and temporal trends in these characteristics during 7 years post approval of Belatacept [ Time Frame: Up to 72 months ] [ Designated as safety issue: No ]
Characteristics of adult kidney-only transplant recipients assessed are age, sex, ethnicity, EBV serostatus, CMV serostatus, organ characteristics, concomitant immunosuppressive medication use, and type of induction medication use.

CNI = calcineurin inhibitors; Timeframe: Every 6 months up to 72 months

Secondary Outcome Measures:

Characteristics of adult EBV seropositive kidney-only transplant recipients treated with Belatacept vs who are treated with CNI-based regimens at time of transplantation & temporal trends in these characteristics during 7 yrs post approval of Belatacept [ Time Frame: Every 6 months up to 72 months ] [ Designated as safety issue: No ]
Characteristics of adult, EBV seropositive, kidney-only transplant recipients assessed are age, sex, ethnicity, CMV serostatus, organ characteristics, concomitant immunosuppressive medication use, and type of induction medication use
Extent of switches to or from Belatacept within one year post-transplant in adult, kidney-only transplant recipients [ Time Frame: Every 6 months up to 72 months ] [ Designated as safety issue: No ]
Characteristics of switchers vs. non-switchers (age, sex, ethnicity, EBV serostatus, CMV serostatus, organ characteristics, concomitant immunosuppressive medication use, and type of induction medication use) [ Time Frame: Every 6 months up to 72 months ] [ Designated as safety issue: No ]
Temporal trend in switches during 7 years post-approval [ Time Frame: Every 6 months up to 72 months ] [ Designated as safety issue: No ]
CMV treatment/prophylaxis by CMV serostatus in adult kidney-only transplant recipients who had anti-CMV therapy data recorded in United Network for Organ Sharing (UNOS) and treated with Belatacept vs. CNIs at transplantation [ Time Frame: Every 6 months up to 72 months ] [ Designated as safety issue: No ]
CMV treatment/prophylaxis by CMV serostatus in adult kidney-only transplant recipients who had anti-CMV therapy data recorded in UNOS and switched to Belatacept, switched from Belatacept, or did not switch [ Time Frame: Every 6 months up to 72 months ] [ Designated as safety issue: No ]
Characteristics of Belatacept users stratified by EBV serostatus, including age, sex, ethnicity, general medical factors, transplant history (organ, date, graft failure date), and donor organ characteristics [ Time Frame: Every 6 months up to 72 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	5000
Study Start Date:	January 2012
Estimated Study Completion Date:	January 2017
Estimated Primary Completion Date:	January 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts
Belatacept treated adult kidney-only transplant recipients All adult kidney-only transplant recipients treated with Nulojix (Belatacept)
CNIs at transplantation

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The cohort for the analyses of all transplants includes all organ transplant recipients who are reported with Belatacept at transplant

Criteria

Inclusion Criteria:

The cohort for the analyses of all transplants includes all organ transplant recipients who are reported with Belatacept at transplant

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670058

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01670058 History of Changes
Other Study ID Numbers:	IM103-074
Study First Received:	August 17, 2012
Last Updated:	August 20, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013