Vascular Remodeling After Living Kidney Donation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-10

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Living Kidney Donation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Living kidney donors

complete vascular exploration before and one year after nephrectomy

Group Type ACTIVE_COMPARATOR

Vascular remodeling characterization

Intervention Type DIAGNOSTIC_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

potential living kidney donors

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)

Group Type SHAM_COMPARATOR

Vascular remodeling characterization

Intervention Type DIAGNOSTIC_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

Interventions

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Vascular 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No