Kidney Transplantation Clinical Trial
— MpRenalOfficial title:
Multiparametric MRI in a Prospective Cohort of Living Kidney Donors, Recipients, and Healthy Controls: Correlations With Markers of Renal Function, Fibrosis and Ageing
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 gold-standard methods for quantifying renal function and fibrosis. The aim of this prospective follow-up 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 gold-standard 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.
Status | Not yet recruiting |
Enrollment | 96 |
Est. completion date | April 1, 2029 |
Est. primary completion date | April 1, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Patrick Schjelderup | Aarhus University Hospital |
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Multiparametric MRI and allograft biopsy at baseline, 3 months, 12 months and 24 months. | |
Secondary | 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) | Multiparametric MRI and DTPA clearance baseline, 3 months, 12 months and 24 months. | |
Secondary | 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. | Multiparametric MRI and biomarkers at baseline, 3 months, 12 months and 24 months. | |
Secondary | 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. | Multiparametric MRI and biomarkers at baseline, 3 months, 12 months and 24 months. |
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