Living Kidney DonationEUGENIANCT05073913
Vascular Remodeling After Living Kidney Donation Study
A study testing Vascular remodeling characterization in people with Living Kidney Donation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Vascular evaluation of candidates to living kidney donation is important because there is an increased risk of end stage renal disease and cardiovascular disease after donation. The implication of vascular remodeling in the vascular morbidity observed in donors has not been established because the parameters of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Living Kidney Donation
- What is being tested?
- Vascular remodeling characterization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2022to Mar 2026
- Phase
- Interventional
- 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
Who may be able to join
- candidate to living kidney donation
- affiliated to national health insurance
- capable of understanding the consequences of participating to the study
- written informed consent
Who cannot join
- pregnancy
- breastfeeding
- allergy to iodinated contrast agents
- allergy to echographic gel, allergy to cutaneous dressings
- cutaneous lesions preventing the ultrasonography probe to be applied on the skin
- participation to a drug trial
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Necker
Paris, 75015
Christophe Legendre, christophe.legendre@aphp.fr
About this study
Official title: Vascular Remodeling After Living Kidney Donation
Vascular evaluation of candidates to living kidney donation is important because there is an increased risk of end stage renal disease and cardiovascular disease after donation. The implication of vascular remodeling in the vascular morbidity observed in donors has not been established because the parameters of vascular remodeling in donors have so far been poorly described. The object of the present study is to study the evolution of vascular remodeling of small, medium and large vessels (until then not evaluable by standard techniques) before and one year after living kidney donation, by dedicated-, non invasive-examinations, which results are associated with cardiovascular risk in the general population. This approach will make it possible to precisely assess the impact of unilateral nephrectomy on vascular remodeling after living donation and to estimate the change in cardiovascular risk attributable to the donation. These results will also help refine the assessment of candidates for kidney donation and potentially open up new strategies to improve selection process of candidates to living kidney donation. Of note, we also plan to evaluate one year after the first exploration potentiel living kidney donors who did not give their kidney due to medical or non medical reasons, as a control group.
- Conditions
- Living Kidney Donation
- Being tested
- Vascular remodeling characterization
- Keywords
- living kidney donors, endothelial function, vascular remodeling, pulse wave velocity, glomerular filtration rate
- Medical subject headings
- Vascular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular remodeling characterizationDiagnostic test
Pulse wave velocity measure High frequency ultrasonography for vascular imaging Endothelial function test Left ventricular mass by echocardiography Measurement of GFR (Glomerular Filtration Rate) with decrease in plasma of Iohexol
| Study group | Role | What they receive |
|---|---|---|
| Living kidney donors | Active comparator | complete vascular exploration before and one year after nephrectomy Receives: Diagnostic Test: Vascular remodeling characterization |
| potential living kidney donors | Sham comparator | complete vascular exploration before and one year after the first exploration (for patients with medical contraindication to donation or who have declined donation after the first exploration) Receives: Diagnostic Test: Vascular remodeling characterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid artery rigidity
Carotid stiffness, as measured by echotracking
Measured: 1 year after living kidney donation or after the first exploration for the non donors
Secondary outcomes (4)
Measured glomerular filtration rate
Measured: 1 year after living kidney donation or after the first exploration for the non donors
Pulse wave velocity
Measured: 1 year after living kidney donation or after the first exploration for the non donors
Endothelial function
Measured Glomerular Filtration Rate (urinary clearance of 99mTc-DTPA) unit: ml/min/1,73 m²
Measured: 1 year after living kidney donation or after the first exploration for the non donors
Small arteries remodeling
Measured: 1 year after living kidney donation or after the first exploration for the non donors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start10 May 2022
- Primary completionMar 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living Kidney DonationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie COURBEBAISSE, MD, PhD, Principal investigator, marie.courbebaisse@aphp.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073913
- Sponsor's protocol ID
- APHP191038
- Other IDs
- IDRCB 2020-A00723-36
- Acronym
- EUGENIA
- Status last verified
- Apr 2023
- First submitted
- 10 May 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Remodeling After Living Kidney Donation
- ClinicalTrials.gov ID
- NCT05073913
- Acronym / sponsor ID
- EUGENIA / APHP191038
- Conditions
- Living Kidney Donation
- Keywords
- living kidney donors, endothelial function, vascular remodeling, pulse wave velocity, glomerular filtration rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 12 Oct 2021 (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.
Vascular evaluation of candidates to living kidney donation is important because there is an increased risk of end stage renal disease and cardiovascular disease after donation. The implication of vascular remodeling in the vascular morbidity observed in donors has not been established because the parameters of vascular remodeling in donors have so far been poorly described. The object of the present study is to study the evolution of vascular remodeling of small, medium and large vessels (until then not evaluable by standard techniques) before and one year after living kidney donation, by dedicated-, non invasive-examinations, which results are associated with cardiovascular risk in the general population. This approach will make it possible to precisely assess the impact of unilateral nephrectomy on vascular remodeling after living donation and to estimate the change in cardiovascular risk attributable to the donation. These results will also help refine the assessment of candidates for kidney donation and potentially open up new strategies to improve selection process of candidates to living kidney donation. Of note, we also plan to evaluate one year after the first exploration potentiel living kidney donors who did not give their kidney due to medical or non medical reasons, as a control group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Living kidney donors | Active comparator | Diagnostic Test: Vascular remodeling characterizationcomplete vascular exploration before and one year after nephrectomy |
| potential living kidney donors | Sham comparator | Diagnostic Test: Vascular remodeling characterizationcomplete vascular exploration before and one year after the first exploration (for patients with medical contraindication to donation or who have declined donation after the first exploration) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- candidate to living kidney donation
- affiliated to national health insurance
- capable of understanding the consequences of participating to the study
- written informed consent
Key exclusion criteria (6 listed)
- pregnancy
- breastfeeding
- allergy to iodinated contrast agents
- allergy to echographic gel, allergy to cutaneous dressings
- cutaneous lesions preventing the ultrasonography probe to be applied on the skin
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 |
|---|---|---|
| Vascular remodeling characterizationPulse wave velocity measure High frequency ultrasonography for vascular imaging Endothelial function test Left ventricular mass by echocardiography Measurement of GFR (Glomerular Filtration Rate) with decrease in plasma of Iohexol | Diagnostic test | Living kidney donors, potential living kidney donors |
Primary outcome
Carotid artery rigidity
Time frame: 1 year after living kidney donation or after the first exploration for the non donors
Carotid stiffness, as measured by echotracking
4 secondary outcomes
Measured glomerular filtration rate
Time frame: 1 year after living kidney donation or after the first exploration for the non donors
Pulse wave velocity
Time frame: 1 year after living kidney donation or after the first exploration for the non donors
Endothelial function
Time frame: 1 year after living kidney donation or after the first exploration for the non donors
Small arteries remodeling
Time frame: 1 year after living kidney donation or after the first exploration for the non donors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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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.
Marie COURBEBAISSE, MD, PhD principal investigator
marie.courbebaisse@aphp.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular remodeling characterization in people with Living Kidney Donation, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 6 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 19 Apr 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. Some participants in this study may receive a placebo. 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 Marie COURBEBAISSE, MD, PhD (+33 1 56 09 39 69, marie.courbebaisse@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid artery rigidity (time frame: 1 year after living kidney donation or after the first exploration for the non donors). 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 19 Apr 2023.