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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01656343
First received: July 31, 2012
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose
  • 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

Condition Intervention
Kidney Transplantation
Transplantation, Kidney
 Drug: Calcineurin inhibitors (CNI)
Drug: Belatacept

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Belatacept and Risk of PTLD in US Renal Transplant Recipients

Resource links provided by NLM:

Drug Information available for: Belatacept
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
    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

  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5000
Study Start Date: June 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Belatacept treated kidney-only transplant recipients Drug: Belatacept
No Intervention
Other Name: Nulojix
CNI treated kidney-only transplant recipients Drug: Calcineurin inhibitors (CNI)
No Intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656343

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01656343     History of Changes
Other Study ID Numbers: IM103-075
Study First Received: July 31, 2012
Last Updated: August 2, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Abatacept
Antirheumatic Agents
 Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013