Transplantation, OrganCTSNCT01476943
Patterns of Use of Belatacept: Analysis of Data From the Collaborative Transplant Study
An observational study of Transplantation, Organ, run by Bristol-Myers Squibb.
Trial summary
The primary purpose is to describe the pattern of Belatacept use at the time of transplant and up to three years post-transplantation for all Belatacept treated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplantation, Organ
- How many people
- 72,392 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2012to 30 Apr 2018
- 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 solid organ transplantation, whose transplant center participates in CTS and who are treated with Belatacept or a CNI based regimen at the time of transplantation
Who may be able to join
- Patients who received solid organ transplantation during study period in one of the transplant centers involved in CTS
Who cannot join
None listed.
About this study
Official title: Belatacept in Renal Transplantation: Patterns of Use Analysis Using the Collaborative Transplant Study (CTS)
The primary purpose is to describe the pattern of Belatacept use at the time of transplant and up to three years post-transplantation for all Belatacept treated patients.
Read the detailed description
Time Perspective: Prospective design, Retrospective data collection and analysis
- Conditions
- Transplantation, Organ
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 |
|---|---|---|
| Patient treated with Belatacept at the time of transplantation | Patients undergoing solid organ transplantation, whose transplant center participates in CTS and who are treated with Belatacept at the time of transplantation | |
| Patient treated with CNI at the time of transplantation | Patients undergoing solid organ transplantation, whose transplant center participates in CTS and who are treated with a Calcineurin inhibitor (CNI) based regimen at the time of transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by Cytomegalovirus (CMV) serostatus
Measured: At the time of transplantation
The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus
Measured: 1 year post transplantation
The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus
Measured: 2 year post transplantation
The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus
Measured: 3 year post transplantation
Secondary outcomes (3)
Extent of switches to or from Belatacept within three years post transplantation, and the temporal trend in switches post regulatory approval of Belatacept
Measured: At transplantation, 12 month, 24 month and 36 month post transplantation
Characteristics of Belatacept users vs. Calcineurin inhibitor (CNIs) users at transplantation
Measured: At the time of transplantation
Characteristics of those who switch to or from Belatacept vs. those who do not switch one year post-transplant
Measured: At transplantation and 12 month post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study start31 Mar 2012
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation, OrganStudies 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
- 72,392 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
- NCT01476943
- Sponsor's protocol ID
- IM103-077
- Acronym
- CTS
- Status last verified
- May 2018
- First submitted
- 8 Nov 2011
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belatacept in Renal Transplantation: Patterns of Use Analysis Using the Collaborative Transplant Study (CTS)
- ClinicalTrials.gov ID
- NCT01476943
- Acronym / sponsor ID
- CTS / IM103-077
- Conditions
- Transplantation, Organ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72,392 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Heidelberg University
- Study start
- 31 Mar 2012 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 22 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 primary purpose is to describe the pattern of Belatacept use at the time of transplant and up to three years post-transplantation for all Belatacept treated patients.
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 |
|---|---|---|
| Patient treated with Belatacept at the time of transplantation | – | –Patients undergoing solid organ transplantation, whose transplant center participates in CTS and who are treated with Belatacept at the time of transplantation |
| Patient treated with CNI at the time of transplantation | – | –Patients undergoing solid organ transplantation, whose transplant center participates in CTS and who are treated with a Calcineurin inhibitor (CNI) based regimen 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 solid organ transplantation, whose transplant center participates in CTS and who are treated with Belatacept or a CNI based regimen at the time of transplantation
Key inclusion criteria (1 listed)
- Patients who received solid organ transplantation during study period in one of the transplant centers involved in CTS
Key exclusion criteria (0 listed)
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
The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by Cytomegalovirus (CMV) serostatus
Time frame: At the time of transplantation
The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus
Time frame: 1 year post transplantation
The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus
Time frame: 2 year post transplantation
The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by CMV serostatus
Time frame: 3 year post transplantation
3 secondary outcomes
Extent of switches to or from Belatacept within three years post transplantation, and the temporal trend in switches post regulatory approval of Belatacept
Time frame: At transplantation, 12 month, 24 month and 36 month post transplantation
Characteristics of Belatacept users vs. Calcineurin inhibitor (CNIs) users at transplantation
Time frame: At the time of transplantation
Characteristics of those who switch to or from Belatacept vs. those who do not switch one year post-transplant
Time frame: At transplantation and 12 month 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 4 May 2018.
- 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 Transplantation, Organ, 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 0 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 4 May 2018. 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?
The number and percent of belatacept users overall, by Epstein-Barr Virus (EBV) serostatus and by Cytomegalovirus (CMV) serostatus (time frame: At the time of transplantation). The study lists 4 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 4 May 2018.