Multifrequency MRE in Evaluation of Chronic Kidney Diseases

February 7, 2026 updated by: Yu Shi, Shengjing Hospital

Multifrequency Renal MR Elastography in Evaluation of Chronic Kidney Diseases: Can Shear Stiffness Evaluate Renal Fibrosis in GFR-normal Patients?

Chronic Kidney Disease (CKD) is a major public health issue, leading to high mortality and the necessity for renal replacement therapy. Kidney fibrosis, resulting from chronic damage to kidney tissue, significantly determines CKD outcomes. Kidney biopsy, the gold standard for assessing fibrosis, is invasive and limited in its ability to reflect the heterogeneous nature of fibrosis. Consequently, there is growing interest in noninvasive methods, particularly Magnetic Resonance Elastography (MRE). MRE, which evaluates tissue stiffness, has shown potential for assessing kidney fibrosis. This study aims to use multifrequency MRE to assess renal fibrosis, focusing particularly on the early stages of CKD, to enhance understanding of its progression and relationship to clinical outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic Kidney Disease (CKD) is a significant public health concern, impacting approximately 10% of the global population. Annually, millions face mortality or require renal replacement therapy due to CKD progression. Kidney fibrosis, a result of chronic parenchymal damage from various glomerular and tubulointerstitial insults, is a primary determinant of outcomes. Accurately assessing the extent and severity of fibrosis is vital for diagnosis and treatment. However, Glomerular Filtration Rate (GFR) may not diminish despite the presence of renal fibrosis, often until extensive damage occurs, owing to the kidney's compensatory abilities. Additionally, GFR reductions may not solely indicate chronic damage or parenchymal fibrosis.

GFR estimates using serum markers offer only rough approximations of kidney fibrosis and can be misleading. The gold standard for assessing kidney fibrosis is a kidney biopsy. However, biopsies are invasive, with potential complications and sampling errors, as they assess less than 1% of the kidney parenchyma. Given the heterogeneous and patchy nature of fibrosis within kidneys, the efficacy of biopsies is further questioned. Serial biopsies to track fibrosis progression are also impractical.

The need for noninvasive, accurate fibrosis assessment has led to research into various imaging techniques. Emerging functional MRI sequences, such as Intravoxel Incoherent Motion (IVIM) and Arterial Spin Labeling (ASL) for perfusion, Blood Oxygen Level Dependent (BOLD) for oxygenation, and T1 mapping for tissue characterization, offer multidimensional insights into renal pathology. Among these, Magnetic Resonance Elastography (MRE) appears particularly promising for directly assessing tissue mechanical properties. MRE, combining MRI with acoustic wave assessment, quantitatively determines tissue viscoelastic properties in response to external mechanical vibration. Initially developed for liver fibrosis assessment, kidney studies have shown that MRE-determined stiffness mildly negatively correlates with CKD stages and positively with fibrosis in renal allografts and diabetic kidneys. While kidney stiffness increases with fibrosis in renal allografts, it decreases with GFR in diabetic nephropathy. In CKD progression, marked by increased fibrosis and decreased GFR, these opposing effects on renal stiffness could limit MRE's applicability in CKD patients. We hypothesize that in early-stage CKD, when GFR is normal or slightly elevated, MRE could effectively determine renal fibrosis severity. To date, no study has specifically explored renal fibrosis and stiffness correlation in early-stage CKD.

Therefore, this study aims to evaluate renal fibrosis using multifrequency 3D-MRE-derived stiffness as a surrogate marker. This involves detecting renal fibrosis prior to CKD changes, distinguishing renal fibrosis from CKD stages, and comparing renal stiffness with clinicopathological correlates in CKD patients. Additionally, we will briefly explore the complementary value of MRE alongside other functional MRI metrics (IVIM, ASL, BOLD, T1 mapping) and investigate their potential efficacy in predicting the prognosis of CKD progression.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Adult patients with CKD stages 1-5 and healthy age-matched adults as controls

Description

Inclusion Criteria:

(1) adults with CKD defined according to the 2024 KDIGO guidelines, with either elevated SCr or abnormal proteinuria ; and (2) renal MRI was performed within 7 days of the renal biopsy.

Exclusion criteria:

(1) genitourinary malignancy, polycystic kidney disease, renal transplantation, or acute renal failure; (2) contraindications for MRI examination; (3) poor image quality; (4) kidney deformity or severe hydronephrosis on MRI; and (5) poorly defined corticomedullary demarcation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CKD Patients
Participants with diagnosed Chronic Kidney Disease will undergo the same MRI protocol as the Healthy Volunteers, including T1-weighted imaging, T2-weighted imaging, MR Elastography (MRE), Intravoxel Incoherent Motion (IVIM), Arterial Spin Labeling (ASL), T1 mapping, Blood Oxygen Level Dependent (BOLD), and Diffusion Weighted Imaging (DWI). The renal MRI will be performed within 7 days of the renal biopsy. In addition to the imaging, these participants will have their blood creatinine, cystatin C, blood pressure etc., measured.
Diagnostic test: Magnetic Resonance Imaging

Both CKD patients and healthy volunteers will undergo a comprehensive MRI protocol, including T1-weighted imaging, T2-weighted imaging, Magnetic Resonance Elastography (MRE), Intravoxel Incoherent Motion (IVIM), Arterial Spin Labeling (ASL), T1 mapping, Blood Oxygen Level Dependent (BOLD), and Diffusion-Weighted Imaging (DWI) to evaluate liver and renal characteristics.

For CKD patients, renal MRI will be performed within 7 days of the renal biopsy . Additionally, blood tests for creatinine and cystatin C, along with blood pressure measurements, will be collected.

Other Names:
  • Arterial Spin Labeling
  • MR elastography
  • Intravoxel Incoherent Motion
  • T1 mapping
  • Blood Oxygen Level Dependent
Healthy Volunteers
Age-matched healthy individuals with no known kidney disease will be recruited. They will undergo the same MRI protocols as the CKD patient group, to establish baseline viscoelasticity parameters for comparison with the CKD patients.
Diagnostic test: Magnetic Resonance Imaging

Both CKD patients and healthy volunteers will undergo a comprehensive MRI protocol, including T1-weighted imaging, T2-weighted imaging, Magnetic Resonance Elastography (MRE), Intravoxel Incoherent Motion (IVIM), Arterial Spin Labeling (ASL), T1 mapping, Blood Oxygen Level Dependent (BOLD), and Diffusion-Weighted Imaging (DWI) to evaluate liver and renal characteristics.

For CKD patients, renal MRI will be performed within 7 days of the renal biopsy . Additionally, blood tests for creatinine and cystatin C, along with blood pressure measurements, will be collected.

Other Names:
  • Arterial Spin Labeling
  • MR elastography
  • Intravoxel Incoherent Motion
  • T1 mapping
  • Blood Oxygen Level Dependent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annual rate of eGFR decline
Time Frame: 24 months
Serum biochemical markers, including eGFR, will be assessed, and a multi-parametric MRI scan (including MRE, IVIM, ASL, BOLD, and T1 mapping) will be performed within 7 days to collect baseline parameters. Following this, eGFR will be monitored every 3 to 6 months for a minimum of 2 years to calculate the annual rate of eGFR decline
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shengjing Hospital

Investigators

  • Principal Investigator: Yu Shi, MD, Shengjing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2022

Primary Completion (Estimated)

June 8, 2027

Study Completion (Estimated)

June 8, 2027

Study Registration Dates

First Submitted

January 1, 2024

First Submitted That Met QC Criteria

January 1, 2024

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 7, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShengjingH-CKD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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