Chronic Kidney Disease (CKD)NCT06202235
Multifrequency MRE in Evaluation of Chronic Kidney Diseases
An observational study of Chronic Kidney Disease (CKD), run by Shengjing Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease (CKD)
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2022to 8 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with CKD stages 1-5 and healthy age-matched adults as controls
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Yu Shi, MD, +8618940259980, 18940259980@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Disease (CKD)
- Being tested
- Magnetic Resonance Imaging
- Keywords
- chronic kidney disease, kidney fibrosis, MR elastography
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
Also called MR elastography, Intravoxel Incoherent Motion, Arterial Spin Labeling, T1 mapping
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Magnetic Resonance Imaging | |
| 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. Receives: Diagnostic Test: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual rate of eGFR decline
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start10 Oct 2022
- Primary completion8 Jun 2027 (estimated)
- Study completion8 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Shi, Shengjing Hospital
- Investigators
- yu shi, MD, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202235
- Sponsor's protocol ID
- ShengjingH-CKD
- Status last verified
- Feb 2026
- First submitted
- 1 Jan 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han JH, Ahn JH, Kim JS. Magnetic resonance elastography for evaluation of renal parenchyma in chronic kidney disease: a pilot study. Radiol Med. 2020 Dec;125(12):1209-1215. doi: 10.1007/s11547-020-01210-1. Epub 2020 May 4.
PubMed 32367323Grossmann M, Tzschatzsch H, Lang ST, Guo J, Bruns A, Durr M, Hoyer BF, Grittner U, Lerchbaumer M, Nguyen Trong M, Schultz M, Hamm B, Braun J, Sack I, Marticorena Garcia SR. US Time-Harmonic Elastography for the Early Detection of Glomerulonephritis. Radiology. 2019 Sep;292(3):676-684. doi: 10.1148/radiol.2019182574. Epub 2019 Jul 9.
PubMed 31287390
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifrequency Renal MR Elastography in Evaluation of Chronic Kidney Diseases: Can Shear Stiffness Evaluate Renal Fibrosis in GFR-normal Patients?
- ClinicalTrials.gov ID
- NCT06202235
- Acronym / sponsor ID
- ShengjingH-CKD
- Conditions
- Chronic Kidney Disease (CKD)
- Keywords
- chronic kidney disease, kidney fibrosis, MR elastography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 8 Jun 2027 (estimated)
- Study completion
- 8 Jun 2027 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD Patients | – | Diagnostic Test: Magnetic Resonance ImagingParticipants 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. |
| Healthy Volunteers | – | Diagnostic Test: Magnetic Resonance ImagingAge-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with CKD stages 1-5 and healthy age-matched adults as controls
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingAlso: MR elastography, Intravoxel Incoherent Motion, Arterial Spin Labeling, T1 mappingBoth 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. | Diagnostic test | CKD Patients, Healthy Volunteers |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Results publication: PubMed 32367323Han JH, Ahn JH, Kim JS. Magnetic resonance elastography for evaluation of renal parenchyma in chronic kidney disease: a pilot study. Radiol Med. 2020 Dec;125(12):1209-1215. doi: 10.1007/s11547-020-01210-1. Epub 2020 May 4.
- Results publication: PubMed 31287390Grossmann M, Tzschatzsch H, Lang ST, Guo J, Bruns A, Durr M, Hoyer BF, Grittner U, Lerchbaumer M, Nguyen Trong M, Schultz M, Hamm B, Braun J, Sack I, Marticorena Garcia SR. US Time-Harmonic Elastography for the Early Detection of Glomerulonephritis. Radiology. 2019 Sep;292(3):676-684. doi: 10.1148/radiol.2019182574. Epub 2019 Jul 9.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease (CKD)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
RecruitingObservational study
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Chronic Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
yu shi, MD principal investigator
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease (CKD), run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yu shi, MD (189 4025 9980, 18940259980@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual rate of eGFR decline (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06202235, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.