NCT06056466

Different Vascular and Renal Parameters in Living Kidney Donors

Completed Last updated 14 August 2024

What this trial tests

trial in Renal Injury in 25 participants. Completed in 15 February 2024.

Timeline

8 May 2019

Primary endpoint
30 November 2023

15 February 2024

Quick facts

Lead sponsor	University of Erlangen-Nürnberg Medical School
Status	Completed
Study type	OBSERVATIONAL
Enrollment	25
Start date	8 May 2019
Primary completion	30 November 2023
Estimated completion	15 February 2024
Sites	1 location across Germany

Conditions studied

• Renal Injury — all drugs for Renal Injury →

Sponsor

University of Erlangen-Nürnberg Medical School

Who can join

Adults 30 to 85, any sex, with Renal Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Sodium quantification in skeletal muscle: comparison between Cartesian gradient-echo and radial ultra-short echo time ²³Na MRI techniques.
   Gerhalter T, Schilling F, Zeitouni N, Linz P, et al · · 2024 · cited 1× · PMID 38773044 · DOI 10.1186/s41747-024-00461-1