Vascular Remodeling After Living Kidney Donation Study

Not Applicable

Recruiting

• Conditions: Living Kidney Donation
• Interventions: Diagnostic Test: Vascular remodeling characterization

• Registration Number: NCT05073913
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-12
• Study Start: 2022-05-10
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-19
• Primary Completion: 2025-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Living kidney donors	Vascular remodeling characterization	complete vascular exploration before and one year after nephrectomy
potential living kidney donors	Vascular remodeling characterization	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)

Primary Outcome Measures

Name	Time	Method
Carotid artery rigidity	1 year after living kidney donation or after the first exploration for the non donors	Carotid stiffness, as measured by echotracking

Secondary Outcome Measures

Name	Time	Method
Pulse wave velocity	1 year after living kidney donation or after the first exploration for the non donors
Measured glomerular filtration rate	1 year after living kidney donation or after the first exploration for the non donors
Endothelial function	1 year after living kidney donation or after the first exploration for the non donors	Measured Glomerular Filtration Rate (urinary clearance of 99mTc-DTPA) unit: ml/min/1,73 m²
Small arteries remodeling	1 year after living kidney donation or after the first exploration for the non donors

Trial Locations

Locations (1)

Hôpital Necker; 🇫🇷 Paris, France