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Vascular Remodeling After Living Kidney Donation Study

Vascular Remodeling After Living Kidney Donation

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05073913
Acronym
EUGENIA
Enrollment
44
Registered
2021-10-12
Start date
2022-05-10
Completion date
2026-03-31
Last updated
2023-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Living Kidney Donation

Keywords

living kidney donors, endothelial function, vascular remodeling, pulse wave velocity, glomerular filtration rate

Brief 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 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.

Interventions

DIAGNOSTIC_TESTVascular remodeling characterization

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* candidate to living kidney donation * affiliated to national health insurance * capable of understanding the consequences of participating to the study * written informed consent

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Carotid artery rigidity1 year after living kidney donation or after the first exploration for the non donorsCarotid stiffness, as measured by echotracking

Secondary

MeasureTime frameDescription
Measured glomerular filtration rate1 year after living kidney donation or after the first exploration for the non donors
Pulse wave velocity1 year after living kidney donation or after the first exploration for the non donors
Endothelial function1 year after living kidney donation or after the first exploration for the non donorsMeasured Glomerular Filtration Rate (urinary clearance of 99mTc-DTPA) unit: ml/min/1,73 m²
Small arteries remodeling1 year after living kidney donation or after the first exploration for the non donors

Countries

France

Contacts

Primary ContactMarie COURBEBAISSE, MD, PhD
marie.courbebaisse@aphp.fr+33 1 56 09 39 69
Backup ContactNatacha NOHILE
natacha.nohile@aphp.fr+33 1 56 09 59 82

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026