Kidneys TransplantationReTransQolNCT02870374
For a Better Interpretation of Quality of Life Scores of Kidney Transplant Patients: Determination of the Minimum Significant Change RetransQol
An observational study of Kidneys Transplantation, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The project team developped and validated a French patient-based health-related quality of life instrument in kidney transplant: the QoL Retrans. The aim of the study is to determine the minimum significant change of the valdiated tool: ReTransQol Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidneys Transplantation
- What is being tested?
- Answering specific quality of life questionnaire in kidneys transplantation population
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Jan 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: Kidneys transplanted patients
Who may be able to join
- Patient with a transplant kidney
Who cannot join
- Patient not able to answer survey
Trial locations and contacts
1 site in 1 country.
About this study
The project team developped and validated a French patient-based health-related quality of life instrument in kidney transplant: the QoL Retrans.
The aim of the study is to determine the minimum significant change of the valdiated tool: ReTransQol
- Conditions
- Kidneys Transplantation
- Being tested
- Answering specific quality of life questionnaire in kidneys transplantation population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Answering specific quality of life questionnaire in kidneys transplantation populationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of change in quality of life in kidneys transplantation patients using ReTransQol
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startJan 2012
- Primary completionMar 2015
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidneys TransplantationStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de MarseilleStéphanie GENTILE, MD/PhD, Principal investigator, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870374
- Sponsor's protocol ID
- 2012-15
- Other IDs
- 2012-A00634-39
- Acronym
- ReTransQol
- Status last verified
- Aug 2016
- First submitted
- 12 Aug 2016
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- For a Better Interpretation of Quality of Life Scores of Kidney Transplant Patients: Determination of the Minimum Significant Change RetransQol
- ClinicalTrials.gov ID
- NCT02870374
- Acronym / sponsor ID
- ReTransQol / 2012-15
- Conditions
- Kidneys Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jan 2017 (estimated)
- First posted
- 17 Aug 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.
The project team developped and validated a French patient-based health-related quality of life instrument in kidney transplant: the QoL Retrans.
The aim of the study is to determine the minimum significant change of the valdiated tool: ReTransQol
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidneys transplanted patients
Key inclusion criteria (1 listed)
- Patient with a transplant kidney
Key exclusion criteria (1 listed)
- Patient not able to answer survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Answering specific quality of life questionnaire in kidneys transplantation population | Behavioural | – |
Primary outcome
Number of change in quality of life in kidneys transplantation patients using ReTransQol
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Individual participant dataSharing planned: No
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Hypothermic Kidney Machine Perfusion With Omnisol
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Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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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.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
Stéphanie GENTILE, MD/PhD principal investigator
Assistance Publique Hôpitaux de Marseille
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 Kidneys Transplantation, run by Assistance Publique Hopitaux De Marseille 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 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: status not confirmed, as of the sponsor's last update on 17 Aug 2016. 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?
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?
Number of change in quality of life in kidneys transplantation patients using ReTransQol (time frame: 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 17 Aug 2016.