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Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study

NCT ID: NCT01471223

Last Updated: 2017-09-19

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

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2017-08-08

Brief Summary

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The purpose of the study is to estimate the incidence rates of Post-transplant Lymphoproliferative Disorder (PTLD), malignancy and hospitalized infections in adult kidney-only transplant recipients treated with Belatacept, and compared the incidences to the incidences in those treated with Calcineurin inhibitor (CNI) based regimens at the time of transplantation.

Detailed Description

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Time Perspective: Prospective design, Retrospective data collection and analysis

Conditions

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Kidney Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients receiving Belatacept in CTS

Patients receiving a 1st kidney-only transplant at a center participating in the CTS and receiving Belatacept at the time of transplantation

No interventions assigned to this group

Patients receiving CNI in CTS

Patients receiving a 1st kidney-only transplant at a center participating in the CTS and receiving CNI at the time of transplantation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 1st kidney only transplant during study, at one of the transplant centers participating in CTS, received Belatacept or a CNI at the time of transplantation

Exclusion Criteria

* Patients with a history of malignancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role collaborator

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

Related Links

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http://www.bms.com/clinical_trials/Pages/home.aspx

BMS Clinical Trials Disclosure

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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IM103-089

Identifier Type: -

Identifier Source: org_study_id