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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB 2020-A00723-36 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Living kidney donors | Active Comparator | complete vascular exploration before and one year after nephrectomy |
|
| potential living kidney donors | Sham Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular remodeling characterization | Diagnostic Test | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie COURBEBAISSE, MD, PhD | Contact | +33 1 56 09 39 69 | marie.courbebaisse@aphp.fr | |
| Natacha NOHILE | Contact | +33 1 56 09 59 82 | natacha.nohile@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marie COURBEBAISSE, MD, PhD | marie.courbebaisse@aphp.fr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Necker | Recruiting | Paris | 75015 | France |
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Two years after the last publication
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).
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| ID | Term |
|---|---|
| D066253 | Vascular Remodeling |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| 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 |