At a glance
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A Prospective, Observational, Non-interventional, Single-center Study to Analyze the Relationship Between Different Vascular and Renal Parameters in Living Kidney Donors With 1 Year Follow-up
In Brief
An observational study for Renal Injury. Completed, enrolled 25 participants across 1 site.
Detailed Summary
Chronic kidney disease (CKD) has a high prevalence globally and is a global health concern. CKD is associated with increased risks of cardiovascular morbidity, mortality and therefore decreased quality of life in any stage of the disease. CKD in early stage is often asymptomatic, which makes the detection of the disease difficult. In this study our goal is to analyze in a clinical trial to what extend renal and vascular parameters correlate with histological kidney changes, especially in a population with eGFR rate of more than 60 mL/min/1.73 m² or pseduonormalized renal function. Our crossectional analysis focus on the association of abnormal vascular and renal parameters with histological renal changes. Our longitudinal analysis focus on the association of histological with renal and/or vascular parameters at baseline, with the renal outcome after kidney donation. Different renal and vascular parameters are obtained non-invasively in potential living kidney donors before donation. Preimplantation kidney biopsies are obtained routinely during donation, which is a standard procedure of our living kidney donation programme. The living kidney donors will be followed up in respect to renal function and blood pressure for one year after donation. Our hypothesis is that histological scoring of renal damage (total renal chronicity scores) correlates with vascular parameters indicating increased stiffness. The primary vascular parameter is wall to lumen ratio of retinal arterioles. Moreover the investigators hypothesize that vascular parameters predicts 24-hour blood pressure and renal outcome (eGFR, albuminuria) one year after donation. To prove this hypothesis overall the investigators will include 25 subjects in this study, having been evaluated before as potential living kidney donors. Total duration of this study for each volunteer is 15 months with total 5 visits, of which 4 are at the Clinical Research Unit (CRC) of the Department of Nephrology, University of Erlangen-Nuremberg and one is the day of kidney donation. This study is important to detect renal damage or CKD in patients with eGFR rate of more than 60 mL/min/1.73 m² or pseduonormalized renal function (CKD stage 1 or 2).