Vascular Remodeling After Living Kidney Donation Study

Study Overview
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Brief Summary
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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.

Official Title
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Vascular Remodeling After Living Kidney Donation

Conditions
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Living Kidney Donation

Intervention / Treatment
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* Diagnostic Test: Vascular remodeling characterization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Living kidney donors<br>complete vascular exploration before and one year after nephrectomy | Diagnostic Test: Vascular remodeling characterization<br>* 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<br>|
| Sham Comparator: potential living kidney donors<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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living kidney donors, endothelial function, vascular remodeling, pulse wave velocity, glomerular filtration rate