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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
November 10, 2011
November 15, 2011
September 19, 2017
March 31, 2012
August 8, 2017   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01471223 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study
Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study (CTS)
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.
Time Perspective: Prospective design, Retrospective data collection and analysis
Observational
Observational Model: Cohort
Time Perspective: Other
Not Provided
Not Provided
Non-Probability Sample
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
Kidney Transplantation
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
August 8, 2017
August 8, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01471223
IM103-089
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Heidelberg University
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2017