Renal TransplantNCT02581644
Assessment of Effectiveness of Belatacept Patient Alert Card in Patients Following Renal Transplantation in a Sample of EU Countries
An observational study of Renal Transplant, run by Bristol-Myers Squibb at 14 sites in 4 countries.
Trial summary
The purpose of the study is to determine a) if the implementation of belatacept patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant
- How many people
- 63 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 29 Nov 2016to 19 May 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: Cohort 1: Patient enrolled by physicians based in hospital and physician renal units Cohort 2: Physicians and nurses based in hospital and physician renal units Cohort 3: Patient enrolled by physicians based in hospital and physician renal units
Who may be able to join
- Patient survey (cohort 1):
- Patients has taken belatacept within the previous 3 months for renal transplantation
- Patient is over 18 years of age
- HCP survey (cohort 2):
- Physician or nurses working in nephrology centers, with at least 1 patient taking belatacept in the previous 6 months for renal transplantation (by prescribing, administering or by follow up)
- Retrospective chart review study (cohort 3):
- Patient survey questionnaire received, Informed Consent Form (ICF) signed (if required)
Who cannot join
- Patient survey:
- Patient has participated in a clinical trial for their renal condition in the previous 12 months
- Currently an employee of BMS
- HCP survey:
- Physicians or nurse who have recruited patients for the Patient survey
- Currently an employee of BMS
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
France8 sites
Local Institution
Besançon, 25030
CHU Brest Hopital La Cavale Blanche
Brest, 29200
CHU Bordeaux Hopital Pellegrin
Burdeux, 33000
CHU Clemont Ferrand
Clermont-Ferrand, 63000
APHP Hopital Henri Mondor
Créteil, 94000
Local Institution
Le Kremlin-Bicêtre, 94270
CHU Toulouse Hopital Rangueli
Toulouse, 31059
CHU Tours Hopital Bretonneau
Tours, 37000
Germany3 sites
Local Institution
Dresden, 1307
Local Institution
Kiel, 24105
UK Mannheim
Mannheim, 68167
About this study
Official title: Evaluation of the Effectiveness of the Belatacept (Nulojix®) Patient Alert Cards in Patients Following Renal Transplantation in European Economic Area Countries
The purpose of the study is to determine a) if the implementation of belatacept patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.
Read the detailed description
3 sub studies: 2 Cross-Sectional and 1 retrospective chart review
- Conditions
- Renal Transplant
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 survey | Adult patients treated with belatacept for renal transplantation | |
| HCP survey | HCP with at least 1 patient taking belatacept | |
| Retrospective chart review study | Adult patients treated with belatacept for renal transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survey: Proportion of patients treated with belatacept who are aware of the existence of the PAC
Measured: At patient enrolment
Patient survey : Proportion of patients treated with belatacept who have received the PAC
Measured: At patient enrolment
Patient survey : Proportion of patients who have utilised the PAC, and the extent of its use
Measured: At patient enrolment
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of belatacept treatment
Measured: At patient enrolment
Patient survey: HCP-patient communication based on responses to specific questions
Measured: At patient enrolment
Patient survey: Proportion of patients with correct responses to behavioral questions
Measured: At patient enrolment
Patient survey: Mean scores for correct responses for questions grouped by objectives
Objectives: distribution, awareness, utility, utilization and knowledge
Measured: At patient enrolment
HCP survey: Proportion of HCPs who prescribe or administer belatacept in nephrology centres who are aware of the PAC
Measured: Day 1
HCP survey: Proportion of HCPs who have utilised the PAC, and the extent of its use
Measured: Day 1
HCP survey: Levels of HCPs' knowledge and comprehension related to the important identified risks of infections and the need to screen for specific infection prior to initiating or administering belatacept
The percentage of HCPs with responses to each question in the HCP questionnaire that would indicate effectiveness of the PAC will be determined: who are aware of the PAC, use the PAC, level of knowledge and comprehension of the risks and mean scores for correct responses
Measured: Day 1
HCP survey: Behavior of HCPs based on responses to behavioral questions
Measured: Day 1
HCP survey: Mean total score for correct responses
Measured: Day 1
HCP survey: Mean scores for correct responses for questions grouped by objectives
Objectives: distribution, awareness, utility, utilization and knowledge
Measured: Day 1
Retrospective chart review study (clinical outcome study): Proportion of serious infections
Measured: Upto 4 years
Secondary outcomes (7)
Major determinants of patients knowledge of the key messages contained in the belatacept PAC based on data collected in the patient questionnaire
Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept
Measured: At patient enrolment
Major determinants of understanding the key messages contained in the PAC based on data collected in the patient questionnaire
Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept
Measured: At patient enrolment
Major determinants of implementation regarding the key messages contained in the PAC based on data collected in the patient questionnaire
Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept
Measured: At patient enrolment
Determinants of Health Care Professional (HCP) understanding and implementation regarding key messages contained in the PAC based on data collected in the patient questionnaire
Determinants: type of HCP, country, age and gender of HCP years in specialty, number of HCPs in the unit, annual number of patients through the unit, number of patients for whom belatacept was prescribed in the previous 12 months, type of practice, type of institution (academic or non-academic), size of town
Measured: Day 1
Retrospective chart review study (clinical outcome study) : proportion of infections leading to discontinuation
Measured: Upto 4 years
Retrospective chart review study (clinical outcome study) : mean time from symptom onset of infection to receipt of medical therapy
Measured: Upto 4 years
Retrospective chart review study (clinical outcome study) : Mean time to diagnosis of graft rejection by biopsy criteria
Measured: Upto 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study start29 Nov 2016
- Primary completion19 May 2017
- Study completion19 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581644
- Sponsor's protocol ID
- IM103-367
- Status last verified
- Jun 2017
- First submitted
- 28 Sep 2015
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Belatacept (Nulojix®) Patient Alert Cards in Patients Following Renal Transplantation in European Economic Area Countries
- ClinicalTrials.gov ID
- NCT02581644
- Acronym / sponsor ID
- IM103-367
- Conditions
- Renal Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 19 May 2017 (actual)
- Study completion
- 19 May 2017 (actual)
- First posted
- 21 Oct 2015 (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 determine a) if the implementation of belatacept patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.
Detailed description
3 sub studies: 2 Cross-Sectional and 1 retrospective chart review
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients survey | – | –Adult patients treated with belatacept for renal transplantation |
| HCP survey | – | –HCP with at least 1 patient taking belatacept |
| Retrospective chart review study | – | –Adult patients treated with belatacept for renal transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort 1: Patient enrolled by physicians based in hospital and physician renal units Cohort 2: Physicians and nurses based in hospital and physician renal units Cohort 3: Patient enrolled by physicians based in hospital and physician renal units
Key inclusion criteria (7 listed)
- Patient survey (cohort 1):
- Patients has taken belatacept within the previous 3 months for renal transplantation
- Patient is over 18 years of age
- HCP survey (cohort 2):
- Physician or nurses working in nephrology centers, with at least 1 patient taking belatacept in the previous 6 months for renal transplantation (by prescribing, administering or by follow up)
Key exclusion criteria (6 listed)
- Patient survey:
- Patient has participated in a clinical trial for their renal condition in the previous 12 months
- Currently an employee of BMS
- HCP survey:
- Physicians or nurse who have recruited patients for the Patient survey
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
Patient survey: Proportion of patients treated with belatacept who are aware of the existence of the PAC
Time frame: At patient enrolment
Patient survey : Proportion of patients treated with belatacept who have received the PAC
Time frame: At patient enrolment
Patient survey : Proportion of patients who have utilised the PAC, and the extent of its use
Time frame: At patient enrolment
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of belatacept treatment
Time frame: At patient enrolment
Patient survey: HCP-patient communication based on responses to specific questions
Time frame: At patient enrolment
Patient survey: Proportion of patients with correct responses to behavioral questions
Time frame: At patient enrolment
Patient survey: Mean scores for correct responses for questions grouped by objectives
Time frame: At patient enrolment
Objectives: distribution, awareness, utility, utilization and knowledge
HCP survey: Proportion of HCPs who prescribe or administer belatacept in nephrology centres who are aware of the PAC
Time frame: Day 1
HCP survey: Proportion of HCPs who have utilised the PAC, and the extent of its use
Time frame: Day 1
HCP survey: Levels of HCPs' knowledge and comprehension related to the important identified risks of infections and the need to screen for specific infection prior to initiating or administering belatacept
Time frame: Day 1
The percentage of HCPs with responses to each question in the HCP questionnaire that would indicate effectiveness of the PAC will be determined: who are aware of the PAC, use the PAC, level of knowledge and comprehension of the risks and mean scores for correct responses
HCP survey: Behavior of HCPs based on responses to behavioral questions
Time frame: Day 1
HCP survey: Mean total score for correct responses
Time frame: Day 1
HCP survey: Mean scores for correct responses for questions grouped by objectives
Time frame: Day 1
Objectives: distribution, awareness, utility, utilization and knowledge
Retrospective chart review study (clinical outcome study): Proportion of serious infections
Time frame: Upto 4 years
7 secondary outcomes
Major determinants of patients knowledge of the key messages contained in the belatacept PAC based on data collected in the patient questionnaire
Time frame: At patient enrolment
Major determinants of understanding the key messages contained in the PAC based on data collected in the patient questionnaire
Time frame: At patient enrolment
Major determinants of implementation regarding the key messages contained in the PAC based on data collected in the patient questionnaire
Time frame: At patient enrolment
Determinants of Health Care Professional (HCP) understanding and implementation regarding key messages contained in the PAC based on data collected in the patient questionnaire
Time frame: Day 1
Retrospective chart review study (clinical outcome study) : proportion of infections leading to discontinuation
Time frame: Upto 4 years
Retrospective chart review study (clinical outcome study) : mean time from symptom onset of infection to receipt of medical therapy
Time frame: Upto 4 years
Retrospective chart review study (clinical outcome study) : Mean time to diagnosis of graft rejection by biopsy criteria
Time frame: Upto 4 years
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 16 Jun 2017.
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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
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplant, run by Bristol-Myers Squibb at 14 sites in 4 countries.
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 7 inclusion and 6 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 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France, Germany, Austria, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Patient survey: Proportion of patients treated with belatacept who are aware of the existence of the PAC (time frame: At patient enrolment). The study lists 14 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 16 Jun 2017.