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Pattern Of Use Of Belatacept In US Transplant Recipients

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ClinicalTrials.gov Identifier: NCT01670058
Recruitment Status : Active, not recruiting
First Posted : August 21, 2012
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
  • 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 or disease
Kidney Transplantation: Transplantation, Kidney

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pattern Of Use Of Belatacept In US Transplant Recipients
Actual Study Start Date : January 31, 2012
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Belatacept
U.S. FDA Resources

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



Primary Outcome Measures :
  1. The prevalence of Belatacept use [ Time Frame: Up to 72 months ]
    Timeframe: Every 6 months up to 72 months

  2. 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 ]
    EBV = Epstein-Barr virus; CMV = cytomegalovirus; Timeframe: Every 6 months up to 72 months

  3. 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 ]

    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 :
  1. 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 ]
    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

  2. 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 ]
  3. 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 ]
  4. Temporal trend in switches during 7 years post-approval [ Time Frame: Every 6 months up to 72 months ]
  5. 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 ]
  6. 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 ]
  7. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670058


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

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01670058     History of Changes
Other Study ID Numbers: IM103-074
First Posted: August 21, 2012    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents