- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05073913
Vascular Remodeling After Living Kidney Donation Study (EUGENIA)
Vascular Remodeling After Living Kidney Donation
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
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
-
-
-
Paris, France, 75015
- Recruiting
- Hopital Necker
-
Contact:
- Christophe Legendre
- Email: christophe.legendre@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Living kidney donors
complete vascular exploration before and one year after nephrectomy
|
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)
|
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
Time Frame: 1 year after living kidney donation or after the first exploration for the non donors
|
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
Time Frame: 1 year after living kidney donation or after the first exploration for the non donors
|
1 year after living kidney donation or after the first exploration for the non donors
|
|
Pulse wave velocity
Time Frame: 1 year after living kidney donation or after the first exploration for the non donors
|
1 year after living kidney donation or after the first exploration for the non donors
|
|
Endothelial function
Time Frame: 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
|
1 year after living kidney donation or after the first exploration for the non donors
|
Small arteries remodeling
Time Frame: 1 year after living kidney donation or after the first exploration for the non donors
|
1 year after living kidney donation or after the first exploration for the non donors
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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)?
IPD Plan Description
IPD Sharing Time Frame
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
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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