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.
Approved as a living kidney donor or recipient of a kidney from a living donor.
Able to cooperate to an MRI examination
Contraindications to MRI due to incompatible foreign objects.
Severe claustrophobia
Office BP < 140/90 mmHg. (use of 1 antihypertensive drug allowed)
Normal eGFR. (CKD-EPI)
Prospective cohort of living kidney donors, recipients and healthy controls. Donors and recipients will be recruited from the Departments of Renal Medicine at Aalborg- and Aarhus University Hospital. Healthy controls will be matched by age and sex to living kidney donors. Based on power calculations we aim to include 32 participants in each cohort. Inclusion period of 2 years is expected and 2 years of follow-up planned.
Cohort
Prospective
Renal transplantation
Procedure/SurgeryOperative procedure - receipt of a kidney
Living kidney donation
Procedure/SurgeryOperative procedure - donation of a kidney
Correlation between MRI-based measures (T1/T2-mapping, ADC, ASL) and fibrosis quantified by morphometric evaluation renal biopsy.
Changes in MRI-based measures will be correlated to changes in allograft fibrosis quantified by morphometric evaluation of renal biopsy.
Correlation between MRI-based measures (T1/T2-mapping, ADC, ASL) and measured GFR.
Changes in MRI-based measures will be correlated to changes in measured GFR. (DTPA clearance)
Diagnostic performance of MRI-based measures and biomarkers as regards to allograft fibrosis.
Receiver operating characteristic curves, sensitivity, specificity, positive- and negative predicitive values will be specified.
Predictive value of MRI-based measures and biomarkers of renal ageing and fibrosis as regards to development of allograft fibrosis and renal function decline.
Multiple regression modelling with MRI-based measures and biomarkers as independent variables and measured GFR and allograft fibrosis as dependent variables.
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Patrick Schjelderup
Lead sponsor
Aalborg University Hospital
Sponsor institution
Aarhus University Hospital
Collaborator
