Vascular Remodeling After Living Kidney Donation Study
EUGENIA
2 other identifiers
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2021
CompletedFirst Posted
Study publicly available on registry
October 12, 2021
CompletedStudy Start
First participant enrolled
May 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedApril 19, 2023
April 1, 2023
2.8 years
May 10, 2021
April 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
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
Study Arms (2)
Living kidney donors
ACTIVE COMPARATORcomplete vascular exploration before and one year after nephrectomy
potential living kidney donors
SHAM COMPARATORcomplete 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)
Interventions
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
Eligibility Criteria
You may qualify if:
- candidate to living kidney donation
- affiliated to national health insurance
- capable of understanding the consequences of participating to the study
- written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Necker
Paris, 75015, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie COURBEBAISSE, MD, PhD
marie.courbebaisse@aphp.fr
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2021
First Posted
October 12, 2021
Study Start
May 10, 2022
Primary Completion
March 1, 2025
Study Completion
March 1, 2026
Last Updated
April 19, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Two years after the last publication
- 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).
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared