Living Kidney Donation Clinical Trial
— EUGENIAOfficial title:
Vascular Remodeling After Living Kidney Donation
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.
| Status | Recruiting |
| Enrollment | 44 |
| Est. completion date | March 2026 |
| Est. primary completion date | March 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Necker | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Measured glomerular filtration rate | 1 year after living kidney donation or after the first exploration for the non donors | ||
| Secondary | Pulse wave velocity | 1 year after living kidney donation or after the first exploration for the non donors | ||
| Secondary | 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 | |
| Secondary | Small arteries remodeling | 1 year after living kidney donation or after the first exploration for the non donors |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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