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Clinical Trials/NCT05073913
NCT05073913RecruitingNot Applicable

Vascular Remodeling After Living Kidney Donation

Assistance Publique - Hôpitaux de Paris2 sites in 1 country44 target enrollmentStarted: May 10, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
44
Locations
2
Primary Endpoint
Carotid artery rigidity

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Pulse wave velocity(1 year after living kidney donation or after the first exploration for the non donors)
  • Measured glomerular filtration rate(1 year after living kidney donation or after the first exploration for the non donors)
  • Endothelial function(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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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