Chronic Kidney Disease Clinical Trial
Official title:
Estimating the Contribution of Renal Function to Endothelial Dysfunction by a Two-cohort Study: Living Kidney Donors and Their Transplant Recipients
Endothelial dysfunction one-year after transplantation mainly depends on
transplant-associated factors and only marginally on reduced renal function.
OBJETIVES Primary objective Estimate the contribution of renal dysfunction to endothelial
dysfunction in two cohorts of patients, living kidney donors and their transplant
recipients.
Secondary objectives
To evaluate in both cohorts of patients before and after nephrectomy/transplantation the
evolution of the following parameters:
1. Renal function (iohexolGFR, proteinuria/microalbuminuria).
2. Blood pressure (24 h ambulatory blood pressure measurement)
3. Surrogate variables of subclinical atherosclerosis (carotid ultrasound, ankle-brachial
index, pulse wave velocity).
DESIGN Non-interventional, prospective, multicenter, longitudinal study of two cohorts:
living kidney donors and their transplant recipients.
HYPOTHESIS
BACKGROUND: Chronic kidney disease (CKD) is associated with endothelial dysfunction, but the
link between cardiovascular risk and CKD is difficult to establish because other conditions
such as diabetes, hypertension and transplant-related factors are present in these patients.
Living donors are healthy individuals that represent a near-ideal experimental model of CKD
since they undergo a time-defined reduction of GFR after nephrectomy in the absence of other
confounding factors present in patients with mild to moderate CKD.
HYPOTHESIS: Reduction of GFR after donation is associated with increased while renal
transplantation is associated with reduced endothelial dysfunction markers.
AIM: To prospectively evaluate biomarkers of endothelial dysfunction and surrogate variables
of subclinical atherosclerosis in a cohort of living kidney donors before and one year after
donation and in their recipients before and one year after transplantation.
PATIENTS AND METHODS: In two cohorts of 60 living kidney donors (1 month before and 1 year
after donation) and in their 60 renal transplant recipients (1 month before and 1 year after
transplantation) the following variables will be recorded: iohexol glomerular filtration
rate (GFR), proteinuria, microalbuminuria, insulinemia, oral glucose tolerance test, total
and LDL/HDL cholesterol, number of carotid plaques and intima-media thickness,
carotid-femoral pulse wave velocity, ankle-brachial index, 24-hours ambulatory monitoring of
blood pressure. The following biomarkers of endothelial dysfunction and subclinical
inflammation will be determined: SVCAM-1, PTX3, ICAM-1, von Willebrand factor, E-selectin,
platelet/endothelial cell adhesion molecule (PECAM1), interleukin 6 (IL-6), soluble receptor
of tumor necrosis factor (sTNFR1 and sTNFR2), high sensitive C reactive protein (hs-CRP) and
soluble TNF-like weak inducer of apoptosis (sTWEAK).
EXPECTED RESULTS. In healthy subjects decrease of renal function after living donation will
be associated with increased endothelial dysfunction markers. On the contrary, after
transplantation a decrease of endothelial dysfunction markers will be observed. Despite at
one year both cohorts of patients will have a similar GFR, the investigators expect that
amelioration of endothelial dysfunction in transplants will be higher than worsening of
endothelial dysfunction in their donors. Thus, the study of these two cohorts will allow
estimating the contribution of renal dysfunction per se and transplant-associated
comorbidities to endothelial dysfunction in chronic kidney disease.
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