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Vascular Remodeling After Living Kidney Donation Study (EUGENIA)

Primary Purpose

Living Kidney Donation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vascular remodeling characterization
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Living Kidney Donation focused on measuring living kidney donors, endothelial function, vascular remodeling, pulse wave velocity, glomerular filtration rate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital NeckerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Living kidney donors

potential living kidney donors

Arm Description

complete vascular exploration before and one year after nephrectomy

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)

Outcomes

Primary Outcome Measures

Carotid artery rigidity
Carotid stiffness, as measured by echotracking

Secondary Outcome Measures

Measured glomerular filtration rate
Pulse wave velocity
Endothelial function
Measured Glomerular Filtration Rate (urinary clearance of 99mTc-DTPA) unit: ml/min/1,73 m²
Small arteries remodeling

Full Information

First Posted
May 10, 2021
Last Updated
April 14, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05073913
Brief Title
Vascular Remodeling After Living Kidney Donation Study
Acronym
EUGENIA
Official Title
Vascular Remodeling After Living Kidney Donation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Living Kidney Donation
Keywords
living kidney donors, endothelial function, vascular remodeling, pulse wave velocity, glomerular filtration rate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Living kidney donors
Arm Type
Active Comparator
Arm Description
complete vascular exploration before and one year after nephrectomy
Arm Title
potential living kidney donors
Arm Type
Sham Comparator
Arm Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
Vascular remodeling characterization
Intervention Description
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
Primary Outcome Measure Information:
Title
Carotid artery rigidity
Description
Carotid stiffness, as measured by echotracking
Time Frame
1 year after living kidney donation or after the first exploration for the non donors
Secondary Outcome Measure Information:
Title
Measured glomerular filtration rate
Time Frame
1 year after living kidney donation or after the first exploration for the non donors
Title
Pulse wave velocity
Time Frame
1 year after living kidney donation or after the first exploration for the non donors
Title
Endothelial function
Description
Measured Glomerular Filtration Rate (urinary clearance of 99mTc-DTPA) unit: ml/min/1,73 m²
Time Frame
1 year after living kidney donation or after the first exploration for the non donors
Title
Small arteries remodeling
Time Frame
1 year after living kidney donation or after the first exploration for the non donors

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie COURBEBAISSE, MD, PhD
Phone
+33 1 56 09 39 69
Email
marie.courbebaisse@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Natacha NOHILE
Phone
+33 1 56 09 59 82
Email
natacha.nohile@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie COURBEBAISSE, MD, PhD
Organizational Affiliation
marie.courbebaisse@aphp.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Legendre
Email
christophe.legendre@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

Vascular Remodeling After Living Kidney Donation Study

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