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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Heidelberg University
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01471223
First received: November 10, 2011
Last updated: August 19, 2014
Last verified: August 2014

November 10, 2011
August 19, 2014
April 2012
April 2018   (final data collection date for primary outcome measure)
  • Incidences of Post-transplant Lymphoproliferative Disorder (PTLD) [ Time Frame: 5 years post transplantation ] [ Designated as safety issue: Yes ]
  • Incidences of hospitalized infections [ Time Frame: 2 years post transplantation ] [ Designated as safety issue: Yes ]
  • Incidences of malignancy [ Time Frame: 5 years post transplantation ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Mortality rate of composite bacterial, fungal, viral, tuberculosis, herpes, and CMV infections [ Time Frame: 2 years post transplantation ] [ Designated as safety issue: Yes ]
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
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.
 
Active, not recruiting
5000
April 2018
April 2018   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01471223
IM103-089
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Heidelberg University
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP