Vascular Remodeling After Living Kidney Donation Study (EUGENIA)

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.

Study Overview

• Status: Recruiting
• Conditions: Living Kidney Donation
• Intervention / Treatment: Diagnostic test: Vascular remodeling characterization

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie COURBEBAISSE, MD, PhD; Phone Number: +33 1 56 09 39 69; Email: marie.courbebaisse@aphp.fr
• Study Contact Backup: Name: Natacha NOHILE; Phone Number: +33 1 56 09 59 82; Email: natacha.nohile@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Hôpital Necker
    • Contact: Christophe Legendre; Email: christophe.legendre@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Living kidney donors; complete vascular exploration before and one year after nephrectomy	Diagnostic test: 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
Sham Comparator: 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)	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carotid artery rigidity	Carotid stiffness, as measured by echotracking	1 year after living kidney donation or after the first exploration for the non donors

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measured glomerular filtration rate		1 year after living kidney donation or after the first exploration for the non donors
Pulse wave velocity		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	1 year after living kidney donation or after the first exploration for the non donors
Small arteries remodeling		1 year after living kidney donation or after the first exploration for the non donors

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: glomerular filtration rate; pulse wave velocity; endothelial function; living kidney donors; vascular remodeling
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Vascular Remodeling
• Other Study ID Numbers: APHP191038; IDRCB 2020-A00723-36 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
• IPD Sharing Time Frame: Two years after the last publication

IPD Sharing Access Criteria

Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision.

Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. contractualization.

Processing of shared data must comply with European General Data Protection Regulation (GDPR).

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No