NCT06210555 Multiparametric MRI in a Prospective Cohort of Living Kidney Donors, Recipients, and Healthy Controls: Correlations With Markers of Renal Function, Fibrosis and Ageing
| NCT ID | NCT06210555 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Patrick Schjelderup |
| Condition | Kidney Transplantation |
| Study Type | OBSERVATIONAL |
| Enrollment | 96 participants |
| Start Date | 2024-10-29 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 96 participants in total. It began in 2024-10-29 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Patrick Schjelderup, MD
PRINCIPAL INVESTIGATOR
Aalborg University Hospital
Frequently Asked Questions
Who can join the NCT06210555 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Kidney Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06210555 currently recruiting?
Yes, NCT06210555 is actively recruiting participants. Contact the research team at pasc@rn.dk for enrollment information.
Where is the NCT06210555 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Aalborg, Denmark.
Who is sponsoring the NCT06210555 clinical trial?
NCT06210555 is sponsored by Patrick Schjelderup. The principal investigator is Patrick Schjelderup, MD at Aalborg University Hospital. The trial plans to enroll 96 participants.
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