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

NCT01656343 | Completed

• 1 other identifier: IM103-075
• Study Type: observational
• Target: 775
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (3)

• Incidence rates of post-transplant lymphoproliferative disorder (PTLD) in adult, EBV seropositive, kidney alone transplant recipients treated with belatacept at the time of transplantation

  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

  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

  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

  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

  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

  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

  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

  Every 6 months for up to 72 months

Study Arms (2)

Belatacept treated kidney-only transplant recipients

Drug: Belatacept

CNI treated kidney-only transplant recipients

Drug: Calcineurin inhibitors (CNI)

Interventions

Calcineurin inhibitors (CNI) DRUG

No Intervention

CNI treated kidney-only transplant recipients

Belatacept DRUG

No Intervention

Also known as: Nulojix

Belatacept treated kidney-only transplant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Publications (1)

• 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.

  PMID: 39792912 DERIVED

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry form
• FDA Safety Alerts and Recalls
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Calcineurin Inhibitors; Abatacept

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 3, 2012
• Study Start: October 31, 2011
• Primary Completion: August 5, 2019
• Study Completion: August 5, 2019
• Last Updated: July 22, 2022

Record last verified: 2022-07