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

An observational study of Kidney Transplantation and Transplantation, Kidney, run by Bristol-Myers Squibb.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Transplantation, Transplantation, Kidney
What is being tested?: Calcineurin inhibitors (CNI) and Belatacept
How many people: 775 participants
Where: No sites listed yet
Study dates: 31 Oct 2011to 5 Aug 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

None listed.

About this study

Official title: 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

Conditions: Kidney Transplantation, Transplantation, Kidney
Being tested: Calcineurin inhibitors (CNI), Belatacept

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Calcineurin inhibitors (CNI)Drug
No Intervention
BelataceptDrug
Also called Nulojix
No Intervention

Study groups in NCT01656343
Study group	Role	What they receive
Belatacept treated kidney-only transplant recipients		Not described Receives: Drug: Belatacept
CNI treated kidney-only transplant recipients		Not described Receives: Drug: Calcineurin inhibitors (CNI)

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence rates of post-transplant lymphoproliferative disorder (PTLD) in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept at the time of transplantation
Measured: 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
Measured: 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
Measured: Every 6 months for up to 72 months

Secondary outcomes (8)

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Measured: Every 6 months for up to 12 months follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 20115 Aug 2019

First posted3 Aug 2012 (estimated)
Study start31 Oct 2011
Primary completion5 Aug 2019
Study completion5 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Kidney TransplantationStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 775 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01656343
Sponsor's protocol ID: IM103-075
Status last verified: Jul 2022
First submitted: 31 Jul 2012
Last updated: 22 Jul 2022
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 39792912

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney

All Kidney Transplantation trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Belatacept and Risk of PTLD in US Renal Transplant Recipients
ClinicalTrials.gov ID: NCT01656343
Acronym / sponsor ID: IM103-075
Conditions: Kidney Transplantation, Transplantation, Kidney
Study type: Observational
Recruitment status: Completed
Enrolment: 775 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 31 Oct 2011 (actual)
Primary completion: 5 Aug 2019 (actual)
Study completion: 5 Aug 2019 (actual)
First posted: 3 Aug 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Belatacept treated kidney-only transplant recipients	–	Drug: Belatacept
CNI treated kidney-only transplant recipients	–	Drug: Calcineurin inhibitors (CNI)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (3 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Calcineurin inhibitors (CNI)No Intervention	Drug	CNI treated kidney-only transplant recipients
BelataceptAlso: NulojixNo Intervention	Drug	Belatacept treated kidney-only transplant recipients

Primary outcome

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
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
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

8 secondary outcomes

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
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
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
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
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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
Derived from this study: PubMed 39792912Cherikh 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.
BMS Clinical Trial InformationLink provided by the sponsor.
Investigator Inquiry formLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

Related trials for Kidney Transplantation

Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplantation and Transplantation, Kidney, run by Bristol-Myers Squibb.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01656343, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.