Pattern Of Use Of Belatacept In US Transplant Recipients

NCT ID: NCT01670058

Last Updated: 2018-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2018-06-12

Brief Summary

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* 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.

Detailed Description

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Conditions

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Kidney Transplantation: Transplantation, Kidney

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Belatacept treated adult kidney-only transplant recipients

All adult kidney-only transplant recipients treated with Nulojix (Belatacept)

No interventions assigned to this group

CNIs at transplantation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

References

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Cherikh WS, Kou TD, Foutz J, Baker TJ, Gomez-Caminero A. Patterns of belatacept use and risk of post-transplant lymphoproliferative disorder in US kidney transplant recipients: An analysis of the Organ Procurement and Transplantation Network database. PLoS One. 2025 Jan 10;20(1):e0311935. doi: 10.1371/journal.pone.0311935. eCollection 2025.

Reference Type DERIVED
PMID: 39792912 (View on PubMed)

Related Links

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Other Identifiers

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IM103-074

Identifier Type: -

Identifier Source: org_study_id

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