Clinical trial NCT05073913: Vascular Remodeling After Living Kidney Donation Study
Official title: Vascular Remodeling After Living Kidney Donation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Living Kidney Donation
Keywords: living kidney donors
endothelial function
vascular remodeling
pulse wave velocity
glomerular filtration rate
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Carotid artery rigidity
timeFrame: 1 year after living kidney donation or after the first exploration for the non donors
Secondary outcomes:
measure: Measured glomerular filtration rate
timeFrame: 1 year after living kidney donation or after the first exploration for the non donors
measure: Pulse wave velocity
timeFrame: 1 year after living kidney donation or after the first exploration for the non donors
measure: Endothelial function
timeFrame: 1 year after living kidney donation or after the first exploration for the non donors
measure: Small arteries remodeling
timeFrame: 1 year after living kidney donation or after the first exploration for the non donors
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker
Study officials:
affiliation: marie.courbebaisse@aphp.fr
name: Marie COURBEBAISSE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: