Renal InsuffiencyPreKiTQoLNCT02154815
Pre-emptive Kidney Transplantation Quality of Life
An observational study of Renal Insuffiency and Kidney Transplantation, run by Nantes University Hospital at 5 sites in France.
Trial summary
The main objective is to assess the psychological impact of pre-emptive kidney transplantation on patients' quality of life taking into account psychological adjustment (response shift), compared to patients who have experienced a short pre-transplant dialysis period of less than 36 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insuffiency, Kidney Transplantation
- What is being tested?
- Questionnaires : Patient-Reported Outcomes
- How many people
- 390 participants
- Where
- 5 sitesFrance
- Study dates
- Sep 2014to 25 Jul 2024
- 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: Adult patients waiting a kidney transplantation
Who may be able to join
- Adult patients with a pre-emptive transplantation from deceased and living donor and patients who have experienced a pre-transplant dialysis period of less than 36 months (matched inclusion on recipient gender and center).
- Only first and single kidney transplantation will be considered.
Who cannot join
- Re-transplantation or simultaneous transplantation (kidney-pancreas for instance)
- Patients under guardianship.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU LYON - Hôpitla E. Herriot - Médecine de transplantation et immunoclinique
Lyon, 69437
CHU MARSEILLE - Hôpital de la Conception - Santé Publique
Marseille, 13005
CHU NANTES - Hôtel Dieu-Jean Monnet - ITUN
Nantes, 44093
CHU NICE - Service de Néphrologie
Nice, 06002
CHU TOULOUSE - Hôpitalt Rangueil - Service de Néphrologie
Toulouse, 61059
About this study
Official title: Evaluation of the Benefits Associated With Pre-emptive Kidney Transplantation. Prospective, Multicenter and Controlled Study of Quality of Life, Psychological Adjustment Processes and Medical Outcomes of Patients Receiving a Pre-emptive Kidney Transplant Compared to a Similar Population of Recipients After a Dialysis Period of Less Than Three Years
The main objective is to assess the psychological impact of pre-emptive kidney transplantation on patients' quality of life taking into account psychological adjustment (response shift), compared to patients who have experienced a short pre-transplant dialysis period of less than 36 months.
Read the detailed description
The following outcomes will also be compared between Patients with Pre-emptive Transplantation and Patients with Dialysis before Transplantation : a) changes in quality of life, subjective well-being, perceived anxiety and depressive disorders as well as perceived stress during follow-up taking into account psychological adjustment (response shift) ; b) The coping strategies (process of managing stressful circumstances) and post-traumatic growth (positive psychological change experienced as a result of the struggle with highly challenging life circumstances) ; c) The 2-year post transplantation graft survival and patient outcomes: evolution of the Graft Filtration Rate, the proteinuria level ; d) The Kidney Transplant Failure Score (KTFS, patent N°0959043) at one year post transplantation ; e) The post-transplantation time to return to work and patients compliance to treatment.
- Conditions
- Renal Insuffiency, Kidney Transplantation
- Being tested
- Questionnaires : Patient-Reported Outcomes
- Keywords
- End Stage Renal Disease, Renal transplantation, Dialysis, Pre-emptive transplantation, Psychological adjustment, Quality of life.
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires : Patient-Reported OutcomesOther
Patient-Reported Outcomes completion every six months prior to surgery, at hospital discharge, and at 3, 6,12, 24, 36, 48, 72 months
| Study group | Role | What they receive |
|---|---|---|
| PPT | Patients with a pre-emptive kidney transplantation from deceased or living donors Receives: Other: Questionnaires : Patient-Reported Outcomes | |
| PDT | Patients who have experienced a pre-transplant dialysis period of less than 36 months Receives: Other: Questionnaires : Patient-Reported Outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life
The change in quality of life, taking into account psychological adjustment of the patient (response shift).
This criterion will be measured by a specifically developed questionnaire : ReTransQol
Measured: through study completion, an average of 5 years
Secondary outcomes (11)
Generic quality of life
Generic QoL will be assessed with the SF36 every 6 months prior to surgery, at hospital discharge and at 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT.
Measured: through study completion, an average of 5 years
Anxiety and depressive disorders
Anxiety and depressive disorders will be assessed every six months prior to surgery, at hospital discharge, and at 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT using the questionnaire HAD (Hospital Anxiety and Depression scale)
Measured: through study completion, an average of 5 years
Subjective well-being
Subjective well-being will be assessed every six months prior to surgery, at hospital discharge and at 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT using the satisfaction with life scale (SWLS)
Measured: through study completion, an average of 5 years
Perceived stress
The perceived stress will be assessed every six months prior to surgery, at hospital discharge, and at 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT with the Perceived Stress Scale
Measured: through study completion, an average of 5 years
Coping strategies
The coping strategies will be assessed at 3, 6,12, 24, 36, 48, 72 months post transplantation and compared between PPT versus PDT with the Brief Cope
Measured: through study completion, an average of 5 years
Posttraumatic growth
The posttraumatic growth will be assessed at 3, 6,12, 24, 36, 48, 72 months post transplantation and compared between PPT versus PDT with the Posttraumatic Growth Inventory (PTGI)
Measured: through study completion, an average of 5 years
Evolution of the Graft Filtration Rate
The evolution of the Graft Filtration Rate (GFR) will be compared between PPT versus PDT. This clinical parameter will be collected at hospital discharge, and 3, 6,12, 24, 36, 48, 72 months post-transplantation. Renal function will be estimated using the 4-variables MDRD formula
Measured: through study completion, an average of 5 years
Evolution of daily proteinuria level
The evolution of the daily proteinuria level will be compared between PPT versus PDT. This clinical parameter will be collected at hospital discharge, and 3, 6,12, 24, 36, 48, 72 months post-transplantation. Conventionally, proteinuria is diagnosed by a simple dipstick test
Measured: through study completion, an average of 5 years
KTFS (Kidney Transplant Failure Score )
The Kidney Transplant Failure Score (KTFS) at one year post transplantation will be compared between PPT versus PDT.
Measured: 12 month
Post-transplantation time to return to work
Measured: 24 month
Compliance of patients
Compliance of patients will be assessed every six months prior to surgery, at hospital discharge, and at 3, 6,12, 24, 36, 48, 72 months and compared between PPT versus PDT with the Girerd questionnaire
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2018
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal InsuffiencyStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique SEBILLE, Study director, Nantes University HospitalAurélie MEURETTE, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154815
- Sponsor's protocol ID
- RC14_0078
- Acronym
- PreKiTQoL
- Status last verified
- Aug 2024
- First submitted
- 28 May 2014
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Sebille V, Hardouin JB, Giral M, Bonnaud-Antignac A, Tessier P, Papuchon E, Jobert A, Faurel-Paul E, Gentile S, Cassuto E, Morelon E, Rostaing L, Glotz D, Sberro-Soussan R, Foucher Y, Meurette A. Prospective, multicenter, controlled study of quality of life, psychological adjustment process and medical outcomes of patients receiving a preemptive kidney transplant compared to a similar population of recipients after a dialysis period of less than three years--The PreKit-QoL study protocol. BMC Nephrol. 2016 Jan 19;17:11. doi: 10.1186/s12882-016-0225-7.
PubMed 26785745
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Benefits Associated With Pre-emptive Kidney Transplantation. Prospective, Multicenter and Controlled Study of Quality of Life, Psychological Adjustment Processes and Medical Outcomes of Patients Receiving a Pre-emptive Kidney Transplant Compared to a Similar Population of Recipients After a Dialysis Period of Less Than Three Years
- ClinicalTrials.gov ID
- NCT02154815
- Acronym / sponsor ID
- PreKiTQoL / RC14_0078
- Conditions
- Renal Insuffiency, Kidney Transplantation
- Keywords
- End Stage Renal Disease, Renal transplantation, Dialysis, Pre-emptive transplantation, Psychological adjustment, Quality of life.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 3 Jun 2014 (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 main objective is to assess the psychological impact of pre-emptive kidney transplantation on patients' quality of life taking into account psychological adjustment (response shift), compared to patients who have experienced a short pre-transplant dialysis period of less than 36 months.
Detailed description
The following outcomes will also be compared between Patients with Pre-emptive Transplantation and Patients with Dialysis before Transplantation : a) changes in quality of life, subjective well-being, perceived anxiety and depressive disorders as well as perceived stress during follow-up taking into account psychological adjustment (response shift) ; b) The coping strategies (process of managing stressful circumstances) and post-traumatic growth (positive psychological change experienced as a result of the struggle with highly challenging life circumstances) ; c) The 2-year post transplantation graft survival and patient outcomes: evolution of the Graft Filtration Rate, the proteinuria level ; d) The Kidney Transplant Failure Score (KTFS, patent N°0959043) at one year post transplantation ; e) The post-transplantation time to return to work and patients compliance to treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPT | – | Other: Questionnaires : Patient-Reported OutcomesPatients with a pre-emptive kidney transplantation from deceased or living donors |
| PDT | – | Other: Questionnaires : Patient-Reported OutcomesPatients who have experienced a pre-transplant dialysis period of less than 36 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients waiting a kidney transplantation
Key inclusion criteria (2 listed)
- Adult patients with a pre-emptive transplantation from deceased and living donor and patients who have experienced a pre-transplant dialysis period of less than 36 months (matched inclusion on recipient gender and center).
- Only first and single kidney transplantation will be considered.
Key exclusion criteria (2 listed)
- Re-transplantation or simultaneous transplantation (kidney-pancreas for instance)
- Patients under guardianship.
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 |
|---|---|---|
| Questionnaires : Patient-Reported OutcomesPatient-Reported Outcomes completion every six months prior to surgery, at hospital discharge, and at 3, 6,12, 24, 36, 48, 72 months | Other | PDT, PPT |
Primary outcome
Change in quality of life
Time frame: through study completion, an average of 5 years
The change in quality of life, taking into account psychological adjustment of the patient (response shift). This criterion will be measured by a specifically developed questionnaire : ReTransQol
11 secondary outcomes
Generic quality of life
Time frame: through study completion, an average of 5 years
Anxiety and depressive disorders
Time frame: through study completion, an average of 5 years
Subjective well-being
Time frame: through study completion, an average of 5 years
Perceived stress
Time frame: through study completion, an average of 5 years
Coping strategies
Time frame: through study completion, an average of 5 years
Posttraumatic growth
Time frame: through study completion, an average of 5 years
Evolution of the Graft Filtration Rate
Time frame: through study completion, an average of 5 years
Evolution of daily proteinuria level
Time frame: through study completion, an average of 5 years
KTFS (Kidney Transplant Failure Score )
Time frame: 12 month
Post-transplantation time to return to work
Time frame: 24 month
Compliance of patients
Time frame: through study completion, an average of 5 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 27 Aug 2024.
- Derived from this study: PubMed 26785745Sebille V, Hardouin JB, Giral M, Bonnaud-Antignac A, Tessier P, Papuchon E, Jobert A, Faurel-Paul E, Gentile S, Cassuto E, Morelon E, Rostaing L, Glotz D, Sberro-Soussan R, Foucher Y, Meurette A. Prospective, multicenter, controlled study of quality of life, psychological adjustment process and medical outcomes of patients receiving a preemptive kidney transplant compared to a similar population of recipients after a dialysis period of less than three years--The PreKit-QoL study protocol. BMC Nephrol. 2016 Jan 19;17:11. doi: 10.1186/s12882-016-0225-7.
- Related InfoLink provided by the sponsor.
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.
Véronique SEBILLE study director
Nantes University Hospital
Aurélie MEURETTE principal investigator
Nantes University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insuffiency and Kidney Transplantation, run by Nantes University Hospital at 5 sites 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 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: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
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?
Change in quality of life (time frame: through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02154815, which also lists 1 linked publication.
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 27 Aug 2024.