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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01471223
First Posted: November 15, 2011
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Heidelberg University
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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.

Condition
Kidney Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Other
Official Title: Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study (CTS)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Incidences of Post-transplant Lymphoproliferative Disorder (PTLD) [ Time Frame: 5 years post transplantation ]
  • Incidences of hospitalized infections [ Time Frame: 2 years post transplantation ]
  • Incidences of malignancy [ Time Frame: 5 years post transplantation ]

Secondary Outcome Measures:
  • Incidence rates of PTLD in adult subgroups of Belatacept- vs. CNI-treated, kidney-only transplant recipients defined by donor-recipient Epstein Barr virus (EBV) serostatus and by age groups [ Time Frame: Every 6 months and 12 months ]
  • Location, mortality, and tumor type of all PTLD cases in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation and in subgroups of these transplant recipients [ Time Frame: Every 6 months and 12 months ]
    Subgroups of the transplant recipients defined by donor-recipient EBV serostatus at the time of transplantation

  • Cumulative incidence of hospitalized infections in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation [ Time Frame: Every 6 months and 12 months ]

    Hospitalized infections for the following infection groups:

    1. Bacterial
    2. fungal
    3. Viral
    4. Tuberculosis
    5. Herpes and
    6. Cytomegalovirus (CMV)

  • Incidence rates of graft rejection in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation [ Time Frame: Every 6 months and 12 months ]
  • Incidence rates of graft failure in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation [ Time Frame: Every 6 months and 12 months ]
  • Mortality rate of composite bacterial, fungal, viral, tuberculosis, herpes, and CMV infections [ Time Frame: 2 years post transplantation ]

Enrollment: 89
Actual Study Start Date: March 31, 2012
Study Completion Date: August 8, 2017
Primary Completion Date: August 8, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
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

Detailed Description:
Time Perspective: Prospective design, Retrospective data collection and analysis
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing 1st kidney only transplantation, whose transplant centers participate in CTS and who are treated with Belatacept or a CNI based regimen at the time of transplantation
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471223


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

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01471223     History of Changes
Other Study ID Numbers: IM103-089
First Submitted: November 10, 2011
First Posted: November 15, 2011
Last Update Posted: September 19, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents