Belatacept and Risk of Post-transplant Lymphoproliferative Disorder in US Renal Transplant Recipients

July 20, 2022 updated by: Bristol-Myers Squibb

Belatacept and Risk of PTLD in US Renal Transplant Recipients

  • To estimate the incidence rates of post-transplant lymphoproliferative disorder (PTLD) in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept at the time of transplantation
  • To estimate the incidence rates of PTLD in adult, EBV seropositive, kidney alone transplant recipients treated with calcineurin inhibitors (CNI)-based regimens at the time of transplantation
  • To compare the PTLD incidence rates in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept to the rates in adult, EBV seropositive, kidney alone transplant recipients treated with CNI-based regimens at the time of transplantation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
775

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult, EBV seropositive, kidney only transplant recipients initiated on belatacept and adult, EBV seropositive, kidney only transplant recipients initiated on CNIs reported to the UNOS during the period of recruiting belatacept users

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Adult,
  • EBV seropositive, Kidney only transplant recipients initiated on belatacept and adult,
  • EBV seropositive, kidney only transplant recipients initiated on CNIs reported to the United Network for Organ Sharing (UNOS) during the period of recruiting belatacept users

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Belatacept treated kidney-only transplant recipients
Drug: Belatacept
No Intervention
Other Names:
  • Nulojix
CNI treated kidney-only transplant recipients
Drug: Calcineurin inhibitors (CNI)
No Intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence rates of post-transplant lymphoproliferative disorder (PTLD) in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept at the time of transplantation
Time Frame: Every 6 months for up to 72 months
Every 6 months for up to 72 months
Incidence rates of PTLD in adult, EBV seropositive, kidney alone transplant recipients treated with calcineurin inhibitors (CNI)-based regimens at the time of transplantation
Time Frame: Every 6 months for up to 72 months
Every 6 months for up to 72 months
Ratio for PTLD incidence rates in adult, EBV seropositive, kidney alone, belatacept treated patients and adult EBV seropositive, kidney alone, CNI-treated patients at the time of transplantation
Time Frame: Every 6 months for up to 72 months
Every 6 months for up to 72 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence rates of PTLD in subgroups of belatacept-treated, adult, kidney alone transplant recipients defined by recipient Epstein-Barr virus (EBV) serostatus (negative or unknown) and by donor to recipient EBV serostatus
Time Frame: Every 6 months for up to 72 months
Every 6 months for up to 72 months
Ratio for PTLD incidence rates in the belatacept-treated subgroups defined by EBV serostatus (negative or unknown) to the rates in corresponding CNI-treated subgroups
Time Frame: Every 6 months for up to 72 months
Every 6 months for up to 72 months
Incidence rates of PTLD in subgroups of belatacept-treated, adult, kidney alone transplant recipients defined by recipient cytomegalovirus (CMV) serostatus and by donor to recipient CMV serostatus
Time Frame: Every 6 months for up to 72 months
Every 6 months for up to 72 months
Ratio for PTLD incidence rates in the belatacept-treated subgroups defined by CMV serostatus to the rates in corresponding CNI-treated subgroups
Time Frame: Every 6 months for up to 72 months
Every 6 months for up to 72 months
Characteristics (age, gender, weight, BMI, use of immunosuppressive medications, and type of induction medications) of PTLD cases, and the location and mortality of PTLD
Time Frame: Every 6 months for up to 72 months
Characteristics in adult, kidney alone transplant recipients treated with belatacept at transplantation and in subgroups of these transplant recipients defined by EBV serostatus and CMV serostatus
Every 6 months for up to 72 months
Ratio for characteristics of PTLD cases, and the location and mortality of PTLD, in adult, kidney alone transplant recipients treated with belatacept at transplantation to those treated with CNI-based regimens at transplantation
Time Frame: Every 6 months for up to 72 months
Every 6 months for up to 72 months
Two year incidence rates of PTLD by calendar year of transplantation in adult, kidney alone transplant recipients treated with belatacept at transplantation, and in subgroups of these transplant recipients defined by EBV serostatus and by CMV serostatus
Time Frame: Every 6 months for up to 24 months
Every 6 months for up to 24 months
Incidence rates of PTLD by immunosuppressive regimen changes in adult, kidney alone transplant recipients who switch to or from belatacept during the period from transplant to the end of one-year follow-up
Time Frame: Every 6 months for up to 12 months follow up
Every 6 months for up to 12 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 5, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM103-075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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