Renal DiseaseParadigmeNCT05529186
Causes of Mortality in Kidney Transplant Recipients
An observational study of Renal Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The causes of mortality in kidney transplant patients and the risk factors for mortality have been widely published. However, there is a high variability according to geographical areas and time. Recent studies suggest that the classical hierarchy of causes of mortality, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Disease
- How many people
- 7,000 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2022to 14 Dec 2023
- 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
- Adult, Older adult
Study population: Adult subject (≥18 years old) with transplantation performed between 01/01/2008 and 31/12/2014
Who may be able to join
- Adult subject (≥18 years old) during transplantation
- Transplantation performed between 01/01/2008 and 31/12/2014
- Kidney transplant subject, double transplants kidney + pancreas, or kidney + islets of Langherans
- Subject previously transplanted other organs
- Subject not objecting, after being informed, to the reuse of their data for the purposes of this research
Who cannot join
- Subject who expressed their opposition to participating in the study
- Subject having received a double transplant during the same operation: kidney + heart, kidney + liver, kidney + lungs
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Néphrologie-Dialyse-Transplantation - CHU de Strasbourg - France
Strasbourg, 67091
Sophie CAILLARD, MD, PhD, 33 3 69 55 51 20, sophie.caillard@chru-strasbourg.fr
Sophie CAILLARD, MD, PhD
About this study
Official title: Causes of Mortality in Kidney Transplant Recipients, a Paradigm Shift
The causes of mortality in kidney transplant patients and the risk factors for mortality have been widely published. However, there is a high variability according to geographical areas and time. Recent studies suggest that the classical hierarchy of causes of mortality, i.e. the predominance of cardiovascular causes of death, could be overturned by the increase in infectious and cancer-related deaths. Investigators will try to highlight this paradigm shift and the related risk factors by studying two large French transplantation databases.
- Conditions
- Renal Disease
- Keywords
- renal disease, kidney transplant
- Medical subject headings
- Kidney Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of the causes of death of kidney transplant recipients presented in the form of percentage
Measured: Six months of starting dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start14 Mar 2022
- Primary completion14 Dec 2023 (estimated)
- Study completion14 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529186
- Sponsor's protocol ID
- 8558
- Acronym
- Paradigme
- Status last verified
- Nov 2023
- First submitted
- 30 Aug 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes of Mortality in Kidney Transplant Recipients, a Paradigm Shift
- ClinicalTrials.gov ID
- NCT05529186
- Acronym / sponsor ID
- Paradigme / 8558
- Conditions
- Renal Disease
- Keywords
- renal disease, kidney transplant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 14 Dec 2023 (estimated)
- Study completion
- 14 Dec 2023 (estimated)
- First posted
- 6 Sep 2022 (actual)
- 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 causes of mortality in kidney transplant patients and the risk factors for mortality have been widely published. However, there is a high variability according to geographical areas and time. Recent studies suggest that the classical hierarchy of causes of mortality, i.e. the predominance of cardiovascular causes of death, could be overturned by the increase in infectious and cancer-related deaths. Investigators will try to highlight this paradigm shift and the related risk factors by studying two large French transplantation databases.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult subject (≥18 years old) with transplantation performed between 01/01/2008 and 31/12/2014
Key inclusion criteria (5 listed)
- Adult subject (≥18 years old) during transplantation
- Transplantation performed between 01/01/2008 and 31/12/2014
- Kidney transplant subject, double transplants kidney + pancreas, or kidney + islets of Langherans
- Subject previously transplanted other organs
- Subject not objecting, after being informed, to the reuse of their data for the purposes of this research
Key exclusion criteria (2 listed)
- Subject who expressed their opposition to participating in the study
- Subject having received a double transplant during the same operation: kidney + heart, kidney + liver, kidney + lungs
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
Distribution of the causes of death of kidney transplant recipients presented in the form of percentage
Time frame: Six months of starting dialysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Disease, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie CAILLARD, MD, PhD (33 3 69 55 51 20, sophie.caillard@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of the causes of death of kidney transplant recipients presented in the form of percentage (time frame: Six months of starting dialysis). 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 8 Nov 2023.