ESRDQUAVIREIN_RDDVNCT02893475
Impact of Preemptive Living Donor Renal Transplantation on Quality of Life , Occupational Rehabilitation and Societal Participation of Transplant Recipients
An observational study of ESRD, run by Central Hospital, Nancy, France.
Trial summary
Living donor (LD) kidney transplantation is currently the best treatment for end-stage renal disease (ESRD) in terms of life expectancy and quality of life. This method allows preemptive transplantation, before beginning dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD
- How many people
- 534 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Apr 2014
- 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: Population-based
Who may be able to join
- age >= 18 years
- LD kidney transplantation from 2004 through 2009
- First LD kidney transplantation in the seven most active kidney transplantation centers in France: Paris Necker, Nancy, Paris Saint Louis, Foch, Nantes, Toulouse and Montpellier
- Patient with a functioning kidney at the time of the study
- Patient able to read and understand French
Who cannot join
- Patient with multiple transplantation including liver transplantation
- Patient unable to read and understand French
- Patient died or lost to follow-up
About this study
Official title: Impact de la durée de Dialyse Avant Greffe rénale Avec Donneur Vivant Sur la qualité de Vie et la réinsertion Professionnelle Des Receveurs
Living donor (LD) kidney transplantation is currently the best treatment for end-stage renal disease (ESRD) in terms of life expectancy and quality of life. This method allows preemptive transplantation, before beginning dialysis.
The main objective of this study will be to investigate quality of life and societal participation in a population of LD kidney transplant recipients comparing preemptive LD transplantation versus non-preemptive transplantation (performed after a period of dialysis).
Read the detailed description
Living donor (LD) kidney transplantation is currently the best treatment for end-stage renal disease (ESRD) in terms of life expectancy and quality of life. This method allows preemptive transplantation, before beginning dialysis.
The main objective of this study will be to investigate quality of life and societal participation in a population of LD kidney transplant recipients comparing preemptive LD transplantation versus non-preemptive transplantation (performed after a period of dialysis).
It is hypothesized that in addition to prolonged graft survival, preemptive LD kidney transplantation is associated with less deterioration of quality of life and better societal participation.
We therefore propose a cross-sectional population-based study to include all patients who underwent LD kidney transplantation from 2004 through 2009 in the seven most active kidney transplantation centers in France. Cross-sectional surveys have been conducted since 2004 by the biomedicine agency in collaboration with the InVS in order to evaluate quality of life among ESRD patients. The most recent survey, QUAVIREIN, is in process but has included only a small number of patients selected at random. We want to broaden the study population beyond the QUAVIREIN sample in order to include the entire population of LD kidney transplant recipients.
The study population will thus include all patients who received a LD kidney transplant from 2004 through 2009 who give their informed consent to participate in the study and have a functional transplant on March 31, 2012. The seven transplantation centers have agreed to participate in the study.
The patients will be identified using the CRISTAL and QUAVIREIN databases. Quality of life, occupational rehabilitation and societal participation data will be collected with a self-administered questionnaire sent to all identified patients, excepting (in order to avoid duplicates) those who have already participated in the QUAVIREIN survey. The methodology and data collection will be the same as for QUAVIREIN. The Department of Epidemiology and Clinical Evaluation (CIC-EC) of the Nancy University Hospital Center will be in charge of the study logistics and organization.
The study hypothesis will be tested by applying univariate then multivariate statistical analysis to the collected data using ad hoc models comparing preemptive transplantation versus non-preemptive transplantation.
- Conditions
- ESRD
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
SF-36 and Retransqol questionnaires
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Societal participation
self-administered questionnaire
Measured: through study completion, an average of 1 year
Professional reintegration
self-administered questionnaire
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startJan 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, 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
- Cross-sectional
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carole Ayav, MD, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893475
- Sponsor's protocol ID
- Quavirein_RDDV1
- Acronym
- QUAVIREIN_RDDV
- Status last verified
- Sep 2016
- First submitted
- 30 Aug 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact de la durée de Dialyse Avant Greffe rénale Avec Donneur Vivant Sur la qualité de Vie et la réinsertion Professionnelle Des Receveurs
- ClinicalTrials.gov ID
- NCT02893475
- Acronym / sponsor ID
- QUAVIREIN_RDDV / Quavirein_RDDV1
- Conditions
- ESRD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 8 Sep 2016 (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.
Living donor (LD) kidney transplantation is currently the best treatment for end-stage renal disease (ESRD) in terms of life expectancy and quality of life. This method allows preemptive transplantation, before beginning dialysis.
The main objective of this study will be to investigate quality of life and societal participation in a population of LD kidney transplant recipients comparing preemptive LD transplantation versus non-preemptive transplantation (performed after a period of dialysis).
Detailed description
Living donor (LD) kidney transplantation is currently the best treatment for end-stage renal disease (ESRD) in terms of life expectancy and quality of life. This method allows preemptive transplantation, before beginning dialysis.
The main objective of this study will be to investigate quality of life and societal participation in a population of LD kidney transplant recipients comparing preemptive LD transplantation versus non-preemptive transplantation (performed after a period of dialysis).
It is hypothesized that in addition to prolonged graft survival, preemptive LD kidney transplantation is associated with less deterioration of quality of life and better societal participation.
We therefore propose a cross-sectional population-based study to include all patients who underwent LD kidney transplantation from 2004 through 2009 in the seven most active kidney transplantation centers in France. Cross-sectional surveys have been conducted since 2004 by the biomedicine agency in collaboration with the InVS in order to evaluate quality of life among ESRD patients. The most recent survey, QUAVIREIN, is in process but has included only a small number of patients selected at random. We want to broaden the study population beyond the QUAVIREIN sample in order to include the entire population of LD kidney transplant recipients.
The study population will thus include all patients who received a LD kidney transplant from 2004 through 2009 who give their informed consent to participate in the study and have a functional transplant on March 31, 2012. The seven transplantation centers have agreed to participate in the study.
The patients will be identified using the CRISTAL and QUAVIREIN databases. Quality of life, occupational rehabilitation and societal participation data will be collected with a self-administered questionnaire sent to all identified patients, excepting (in order to avoid duplicates) those who have already participated in the QUAVIREIN survey. The methodology and data collection will be the same as for QUAVIREIN. The Department of Epidemiology and Clinical Evaluation (CIC-EC) of the Nancy University Hospital Center will be in charge of the study logistics and organization.
The study hypothesis will be tested by applying univariate then multivariate statistical analysis to the collected data using ad hoc models comparing preemptive transplantation versus non-preemptive transplantation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population-based
Key inclusion criteria (5 listed)
- age >= 18 years
- LD kidney transplantation from 2004 through 2009
- First LD kidney transplantation in the seven most active kidney transplantation centers in France: Paris Necker, Nancy, Paris Saint Louis, Foch, Nantes, Toulouse and Montpellier
- Patient with a functioning kidney at the time of the study
- Patient able to read and understand French
Key exclusion criteria (3 listed)
- Patient with multiple transplantation including liver transplantation
- Patient unable to read and understand French
- Patient died or lost to follow-up
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
Quality of life
Time frame: through study completion, an average of 1 year
SF-36 and Retransqol questionnaires
2 secondary outcomes
Societal participation
Time frame: through study completion, an average of 1 year
Professional reintegration
Time frame: through study completion, an average of 1 year
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 8 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Carole Ayav, MD principal investigator
CHRU de Nancy
Questions about this trial
What is this clinical trial studying?
An observational study of ESRD, run by Central Hospital, Nancy, 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 3 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 8 Sep 2016. 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?
Quality of life (time frame: through study completion, an average of 1 year). 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 Sep 2016.