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Non-Invasive Magnetic Resonance Imaging Biomarkers to Evaluate Histology Proven Kidney Fibrosis in Chronic Kidney Disease

Non-Invasive Magnetic Resonance Imaging Biomarkers to Evaluate Histology Proven Kidney Fibrosis in Chronic Kidney Disease: A Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000855729
Acronym
NIMBLE-CKD
Enrollment
15
Registered
2022-06-17
Start date
2024-07-31
Completion date
2026-06-01
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Chronic kidney disease (CKD) is increasingly becoming more common, and is associated with increased disability and death rates. The best predictor for progression to kidney failure is the amount of kidney scarring detected on a biopsy. Biopsies are useful however are limited by their invasive nature and inability to collect large or multiple samples. MRI is used in other organs like the heart and the liver to check for scarring, but is not yet available for the kidney. The NIMBLE-CKD project aims to develop an MRI marker to estimate the amount of kidney scarring by comparing images with biopsy samples. Ultimately this will provide a less intrusive and safer way to detect and monitor CKD, with a hope to guide early treatment and prevent kidney failure.

Interventions

Patients with chronic kidney disease (CKD) who require a kidney biopsy (native and transplant) will undergo contrast-enhanced kidney magnetic resonance imaging (MRI). The maximum anticipated time of scanning will be 1 hour, and participants will undergo a single parametric scan (utilising 8 different MRI techniques including volumetry, T1/T2/T2* mapping, phase contrast, diffusion weighted imaging, dynamic contrast enhancement and post-contrast T1-mapping) within 1 month following their kidney bi

Patients with chronic kidney disease (CKD) who require a kidney biopsy (native and transplant) will undergo contrast-enhanced kidney magnetic resonance imaging (MRI). The maximum anticipated time of scanning will be 1 hour, and participants will undergo a single parametric scan (utilising 8 different MRI techniques including volumetry, T1/T2/T2* mapping, phase contrast, diffusion weighted imaging, dynamic contrast enhancement and post-contrast T1-mapping) within 1 month following their kidney biopsy. A single intravenous injection of a gadolinium-based contrast agent (Dotarem) will be administered at 0.05mmol/kg via a peripheral intravenous cannula. The scan will be conducted by a MRI radiographer, and an MRI safety checklist will be conducted for each participant prior to scanning.

Sponsors

Professor Martin Ugander
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

All participants (CKD and healthy volunteers) -Willing and able to provide informed consent Healthy volunteers: - No known medical conditions CKD participants: - Baseline eGFR > 15ml/min/1.73m2 - Clinical indication to undergo kidney biopsy (including native and transplanted kidney)

Exclusion criteria

Contraindication to MRI Contraindication to Gadolinium-based contrast agents Dialysis dependent CKD Pregnant or breastfeeding females

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026