Pattern Of Use Of Belatacept In US Transplant Recipients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01670058
First received: August 17, 2012
Last updated: August 4, 2014
Last verified: August 2014
  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:


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: June 2017
Estimated Primary Completion Date: June 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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
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 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014