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Clinical Trials in Denmark / NCT06210555
Recruiting Observational

Multiparametric MRI in a Prospective Cohort of Living Kidney Donors, Recipients, and Healthy Controls: Correlations With Markers of Renal Function, Fibrosis and Ageing

NCT06210555 · tracked via the Priya Life Science Denmark tracker
Sponsor
Patrick Schjelderup
Phase
Observational
Started
2024-10-29
Last updated
2026-08-27

Condition(s) studied

Kidney TransplantationMultiparametric Magnetic Resonance ImagingLiving DonorsRenal FibrosisSenescence

Investigational drug(s) / intervention(s)

Renal transplantationLiving kidney donation

Renal transplantation: Operative procedure - receipt of a kidney

Living kidney donation: Operative procedure - donation of a kidney

Study summary

Development of renal fibrosis is the irreversible culmination of various renal diseases and independently predicts adverse outcomes. Currently renal fibrosis can only be diagnosed by performing a renal biopsy. The procedure is invasive and is limited by sampling bias.

In recent years there has been a significant development in magnetic resonance imaging (MRI) based techniques. MRI can provide highly detailed anatomical images. Other MRI measures allow quantitative measurements of perfusion, oxygenation, tissue stiffness and diffusion of water molecules within tissue. The combination of several MRI techniques sensitive to different biophysical tissue properties in a single scan session is referred to as multiparametric MRI (mpMRI).

Emerging evidence suggests that mpMRI could represent a method for indirect characterization of renal microstructure and extent of fibrosis. So far, studies performed in living kidney donors and recipients have been mostly cross-sectional. For mpMRI to transition to the clinical setting there is a need for validation of MRI-based measures with currently used reference methods for quantifying renal function and fibrosis.

The aim of this longitudinal observational study in a cohort of living kidney donors, recipients and healthy controls is to investigate the utility of repeated mpMRI over a period of 2 years. MRI-based measures will be compared to current reference methods for quantifying renal function and fibrosis.

The investigators hypothesize that there will be significant correlations between MRI-based measures, renal function determined by precise measurement of glomerular filtration rate and extent of fibrosis determined by renal biopsy. MRI-based measures are expected to be predictive of renal function decline and development of renal fibrosis.

This study could provide valuable data that will be helpful in moving the field of renal mpMRI forward, with the goal of providing a novel and non-invasive method for the diagnosis of renal pathology.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Living kidney donors and transplant recipients: Inclusion Criteria: * Approved as a living kidney donor or recipient of a kidney from a living donor. * Able to cooperate to an MRI examination Exclusion Criteria: * Contraindications to MRI due to incompatible foreign objects. * Severe claustrophobia Healthy controls: Inclusion Criteria: * Office BP \< 140/90 mmHg. (use of 1 antihypertensive drug allowed) * Normal eGFR. (CKD-EPI) * Urine albumin-to-creatinine ratio \< 30 mg/g. * Dipstick negative for hematuria and proteinuria. * Able to cooperate to an MRI examination. Exclusion Criteria: * Contraindications to MRI due to incompatible foreign objects. * Severe claustrophobia. * Pregnancy. * Condition(s) that would exclude living kidney donation.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Department of Renal Medicine, Aarhus University Hospital Aarhus Central Jutland Recruiting
Department of Nephrology, Aalborg University Hospital Aalborg North Denmark Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06210555 on ClinicalTrials.gov ↗ ← All trials in Denmark