Renal Transplant Candidate for Right KidneyDONORNCT05282381
Evaluation of Regret in Kidney Transplantation
An observational study of Renal Transplant Candidate for Right Kidney and Renal Transplant Candidate for Left Kidney, run by University Hospital, Lille at 1 site in France.
Trial summary
Decisional regret is a negative feeling, involving distress or remorse following a decision. This has been studied in several areas such as psychology, economy or marketing. Patients suffering from end-stage renal disease may choose between dialysis and transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant Candidate for Right Kidney, Renal Transplant Candidate for Left Kidney
- What is being tested?
- DRS : Decision Regret Scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2022to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 who received a kidney transplant in the nephrology department of the Lille University Hospital
Who may be able to join
- Kidney transplantation in the Lille University Hospital
- Functional kidney graft after 28 days post transplantation
Who cannot join
- Previous other solid organ transplant
- Combined transplantation (kidney and liver for example)
- Cognitive disorders
- Lack of French language skill
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decisional Regret in a Prospective Cohort of Renal Transplant Recipients: the DONOR Study
Decisional regret is a negative feeling, involving distress or remorse following a decision. This has been studied in several areas such as psychology, economy or marketing. Patients suffering from end-stage renal disease may choose between dialysis and transplantation. This decision-making process is shared with the nephrologist, who explained to the patient the pros and cons of these two possibilities. Although transplantation offers a better life expectancy and quality of life than dialysis, nothing is known about the proportion of patients regretting their choice to be transplanted. The DONOR study aims to determine the proportion of patients regretting their decision, in a prospective cohort of renal transplant recipients. The decisional regret will be assessed by the DRS ("Decisional Regret Scale"), associated with the RetransQoL, a quality of life questionnaire.
- Being tested
- DRS : Decision Regret Scale
- Keywords
- Decisional regret, Kidney transplantation, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRS : Decision Regret ScaleBehavioural
The DRS is a self-administered questionnaire including 5 items assessing decisional regret in a score graduated between 0 and 100 (0 = no regret).This scale is associated with the ReTransQoL, a specific quality of life questionnaire.
Questionnaires are administrated at 1, 3, 6 and 12 months post-transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Cohort of renal transplant recipients | Not described Receives: Behavioral: DRS : Decision Regret Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional regret at 12 months post kidney transplantation, defined as a score ≥30 on the Decisional Regret Scale
The decisional regret scale consists of five items addressing the notion of regret from different perspectives. The patient is asked to respond to each item using a 5-point Likert-type scale. The results of the Decisional Regret Scale are converted into a score from 0 to 100, with values increasing in multiples of 5. A score of 0 means no regret.
Three categories of the DRE score were created: no regret (score = 0), low regret (score between 5 and 25), and moderate to high regret (score ≥ 30
Measured: At 12 months post-transplantation
Secondary outcomes (3)
Specific Quality of Life Scale (ReTransQoL)
The ReTransQoL (Renal Transplant Quality of Life) questionnaire is a quality of life related-questionnaire, specific for kidney transplant recipients and developed by Gentile et al. in 2008 (Gentile et al, Health Qual Life Outcomes, 2008). It consists in 49 items, divided into 5 dimensions: Physical Health, Medical Care, Fear of losing the Graft, Treatment and Mental Health. This results in a quality of life score, from 0 to 100 (0 being the lowest quality of life score).
Measured: At 1, 3, 6 and 12 months post-transplantation
Variation of decisional regret over time, following kidney transplantation, using the Decisional Regret Scale
The decisional regret scale consists of five items addressing the notion of regret from different perspectives. The patient is asked to respond to each item using a 5-point Likert-type scale. The results of the Decisional Regret Scale are converted into a score from 0 to 100, with values increasing in multiples of 5. A score of 0 means no regret.
Three categories of the DRE score were created: no regret (score = 0), low regret (score between 5 and 25), and moderate to high regret (score ≥ 30
Measured: At 1, 3, 6 and 12 months post-transplantation
Identification of biological, psychological and sociological risk factors for decisional regret at 12 months post kidney transplantation, defined as a score ≥30 on the Decisional Regret Scale
The decisional regret scale consists of five items addressing the notion of regret from different perspectives. The patient is asked to respond to each item using a 5-point Likert-type scale. The results of the Decisional Regret Scale are converted into a score from 0 to 100, with values increasing in multiples of 5. A score of 0 means no regret.
Three categories of the DRE score were created: no regret (score = 0), low regret (score between 5 and 25), and moderate to high regret (score ≥ 30
Measured: At baseline, and during the 12 months follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start3 Jun 2022
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplant Candidate for Right KidneyStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehdi Maanaoui, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282381
- Sponsor's protocol ID
- 2021_0272
- Other IDs
- 2021-A02002-39
- Acronym
- DONOR
- Status last verified
- May 2026
- First submitted
- 17 Feb 2022
- Last updated
- 14 May 2026
- 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 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decisional Regret in a Prospective Cohort of Renal Transplant Recipients: the DONOR Study
- ClinicalTrials.gov ID
- NCT05282381
- Acronym / sponsor ID
- DONOR / 2021_0272
- Keywords
- Decisional regret, Kidney transplantation, Quality of life
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 16 Mar 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.
Decisional regret is a negative feeling, involving distress or remorse following a decision. This has been studied in several areas such as psychology, economy or marketing. Patients suffering from end-stage renal disease may choose between dialysis and transplantation. This decision-making process is shared with the nephrologist, who explained to the patient the pros and cons of these two possibilities. Although transplantation offers a better life expectancy and quality of life than dialysis, nothing is known about the proportion of patients regretting their choice to be transplanted. The DONOR study aims to determine the proportion of patients regretting their decision, in a prospective cohort of renal transplant recipients. The decisional regret will be assessed by the DRS ("Decisional Regret Scale"), associated with the RetransQoL, a quality of life questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of renal transplant recipients | – | Behavioral: DRS : Decision Regret Scale |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received a kidney transplant in the nephrology department of the Lille University Hospital
Key inclusion criteria (2 listed)
- Kidney transplantation in the Lille University Hospital
- Functional kidney graft after 28 days post transplantation
Key exclusion criteria (4 listed)
- Previous other solid organ transplant
- Combined transplantation (kidney and liver for example)
- Cognitive disorders
- Lack of French language skill
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 |
|---|---|---|
| DRS : Decision Regret ScaleThe DRS is a self-administered questionnaire including 5 items assessing decisional regret in a score graduated between 0 and 100 (0 = no regret).This scale is associated with the ReTransQoL, a specific quality of life questionnaire. Questionnaires are administrated at 1, 3, 6 and 12 months post-transplantation. | Behavioural | Cohort of renal transplant recipients |
Primary outcome
Decisional regret at 12 months post kidney transplantation, defined as a score ≥30 on the Decisional Regret Scale
Time frame: At 12 months post-transplantation
The decisional regret scale consists of five items addressing the notion of regret from different perspectives. The patient is asked to respond to each item using a 5-point Likert-type scale. The results of the Decisional Regret Scale are converted into a score from 0 to 100, with values increasing in multiples of 5. A score of 0 means no regret. Three categories of the DRE score were created: no regret (score = 0), low regret (score between 5 and 25), and moderate to high regret (score ≥ 30
3 secondary outcomes
Specific Quality of Life Scale (ReTransQoL)
Time frame: At 1, 3, 6 and 12 months post-transplantation
Variation of decisional regret over time, following kidney transplantation, using the Decisional Regret Scale
Time frame: At 1, 3, 6 and 12 months post-transplantation
Identification of biological, psychological and sociological risk factors for decisional regret at 12 months post kidney transplantation, defined as a score ≥30 on the Decisional Regret Scale
Time frame: At baseline, and during the 12 months follow-up period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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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.
Mehdi Maanaoui, MD principal investigator
University Hospital, Lille
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 Transplant Candidate for Right Kidney and Renal Transplant Candidate for Left Kidney, run by University Hospital, Lille 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Decisional regret at 12 months post kidney transplantation, defined as a score ≥30 on the Decisional Regret Scale (time frame: At 12 months post-transplantation). 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 14 May 2026.