Text Size

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
History of Changes

August 17, 2012
August 20, 2012
January 2012
January 2017   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01670058 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pattern Of Use Of Belatacept In US Transplant Recipients
Pattern Of Use Of Belatacept In US Transplant Recipients
  • 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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

The cohort for the analyses of all transplants includes all organ transplant recipients who are reported with Belatacept at transplant
Kidney Transplantation: Transplantation, Kidney
Not Provided
  • Belatacept treated adult kidney-only transplant recipients
    All adult kidney-only transplant recipients treated with Nulojix (Belatacept)
  • CNIs at transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
5000
January 2017
January 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01670058
IM103-074
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP