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 20, 2012
Last verified: August 2012
  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: 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 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 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 April 16, 2014