Kidney TransplantationCTSNCT01471223
Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study
An observational study of Kidney Transplantation, run by Bristol-Myers Squibb.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2012to 8 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients with a history of malignancy
About this study
Official title: 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.
Read the detailed description
Time Perspective: Prospective design, Retrospective data collection and analysis
- Conditions
- Kidney Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of Post-transplant Lymphoproliferative Disorder (PTLD)
Measured: 5 years post transplantation
Incidences of hospitalized infections
Measured: 2 years post transplantation
Incidences of malignancy
Measured: 5 years post transplantation
Secondary outcomes (6)
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
Measured: 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
Subgroups of the transplant recipients defined by donor-recipient EBV serostatus at the time of transplantation
Measured: Every 6 months and 12 months
Cumulative incidence of hospitalized infections in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation
Hospitalized infections for the following infection groups:
- Bacterial
- fungal
- Viral
- Tuberculosis
- Herpes and
- Cytomegalovirus (CMV)
Measured: Every 6 months and 12 months
Incidence rates of graft rejection in adult kidney-only transplant recipients treated with Belatacept vs. CNI-based regimens at the time of transplantation
Measured: 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
Measured: Every 6 months and 12 months
Mortality rate of composite bacterial, fungal, viral, tuberculosis, herpes, and CMV infections
Measured: 2 years post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (estimated)
- Study start31 Mar 2012
- Primary completion8 Aug 2017
- Study completion8 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Heidelberg University
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471223
- Sponsor's protocol ID
- IM103-089
- Acronym
- CTS
- Status last verified
- Sep 2017
- First submitted
- 10 Nov 2011
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant Study (CTS)
- ClinicalTrials.gov ID
- NCT01471223
- Acronym / sponsor ID
- CTS / IM103-089
- Conditions
- Kidney Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Heidelberg University
- Study start
- 31 Mar 2012 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 8 Aug 2017 (actual)
- First posted
- 15 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Time Perspective: Prospective design, Retrospective data collection and analysis
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with a history of malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by Bristol-Myers Squibb.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidences of Post-transplant Lymphoproliferative Disorder (PTLD) (time frame: 5 years post transplantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.