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

NCT06210555 | Recruiting

• 1 other identifier: Protocol_v2
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Kidney Transplantation; Multiparametric Magnetic Resonance Imaging; Living Donors; Renal Fibrosis; Senescence

Keywords

MRI; Multiparametric; Renal transplantation; Fibrosis; Kidney donor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation between MRI-based measures (T1/T2-mapping, ADC, ASL) and measured GFR.

  Multiparametric MRI and DTPA clearance baseline, 3 months, 12 months and 24 months.

• Diagnostic performance of MRI-based measures and biomarkers as regards to allograft fibrosis.

  Multiparametric MRI and biomarkers at baseline, 3 months, 12 months and 24 months.

• Predictive value of MRI-based measures and biomarkers of renal ageing and fibrosis as regards to development of allograft fibrosis and renal function decline.

  Multiparametric MRI and biomarkers at baseline, 3 months, 12 months and 24 months.

Study Arms (3)

Living kidney donors

Living kidney donors

Procedure: Living kidney donation

Transplant recipients

Recipients of kidneys from living donors

Procedure: Renal transplantation

Healthy controls

Age- and sex matched healthy controls (Living kidney donors)

Interventions

Renal transplantation PROCEDURE

Operative procedure - receipt of a kidney

Transplant recipients

Living kidney donation PROCEDURE

Operative procedure - donation of a kidney

Living kidney donors

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Approved as a living kidney donor or recipient of a kidney from a living donor.
• Able to cooperate to an MRI examination

You may not qualify if:

• Contraindications to MRI due to incompatible foreign objects.
• Severe claustrophobia
• Healthy controls:
• 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.
• Contraindications to MRI due to incompatible foreign objects.
• Severe claustrophobia.
• Pregnancy.
• Condition(s) that would exclude living kidney donation.

Sponsors & Collaborators

• Patrick Schjelderup: lead
• Aarhus University Hospital: collaborator

Study Sites (2)

Department of Renal Medicine, Aarhus University Hospital

Aarhus, Central Jutland, 8200, Denmark

RECRUITING

Department of Nephrology, Aalborg University Hospital

Aalborg, North Denmark, 9200, Denmark

RECRUITING

Related Publications (28)

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Biospecimen

Retention: SAMPLES WITH DNA

Renal biopsies Blood- and urine: markers of renal ageing and fibrosis.

MeSH Terms

Conditions

Fibrosis

Interventions

Kidney Transplantation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Patrick Schjelderup, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Schjelderup, MD

CONTACT

+4597666015; pasc@rn.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: October 29, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)