HypertensionNCT04508049
A Study to Evaluate Renal Fibrosis Using MRI Techniques
A study testing qMT-MRI to detect fibrosis. in people with Hypertension and Renovascular, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether or not an MRI technique (quantitative magnetization transfer or qMT) in narrowing human kidneys is feasible, reproducible, and predicts recovery. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hypertension, Renovascular
- What is being tested?
- qMT-MRI to detect fibrosis.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to Dec 2028
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between ages 40 and 80 years old.
- Patients with hypertension (BP>140/90 mmHg) and/or requirement for two or more antihypertensive medications for more than 4 weeks.
- Serum creatinine under 2.2 and 2.0 mg/dL for men and women, respectively (Caucasians). Values for African-American subjects are slightly higher (2.4 mg/dL, males; 2.1 mg/dL females).
- No contraindications to angiography: severe contrast allergy.
- No contraindications to no-contrast MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia.
- Patients have the ability to comply with protocol
- Patients are competent and able to provide written informed consent
Who cannot join
- Patient has serum creatinine >2.2 mg/dL for men and >2.0 mg/dL for women (Caucasians); >2.4 mg/dL for men and >2.1 mg/dL for women (African American).
- RVD in a solitary kidney
- Patients have clinically significant medical conditions within the prior six months: e.g. myocardial infarction, congestive heart failure, stroke, that would, in the opinion of the investigators, compromise the safety of the patient.
- Uncontrolled hypertension (Systolic BP >180 mmHg despite therapy).
- Diabetes requiring insulin or oral hypoglycemic medications.
- Evidence of hepatitis B or C, or HIV infection.
Show all 18Show fewer
- Requirement for potentially nephrotoxic drugs; e.g., non-steroidal anti-inflammatory drugs.
- Cardiac ejection fraction less than 30%.
- History of deep venous thrombosis within 3 months of enrollment.
- Kidney transplant.
- Pacemaker, implantable defibrillator or other contraindication to MRI
- Inability to comply with breath-hold for 20 seconds
- Any active malignancy and undergoing therapy
- Patients are pregnant.
- Kidney or ureteric stone
- Another known acute or chronic kidney disease
- Federal medical center inmates.
- Latex allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Quantitative Magnetization Transfer MRI for Evaluation of Renal Fibrosis
The purpose of this study is to evaluate whether or not an MRI technique (quantitative magnetization transfer or qMT) in narrowing human kidneys is feasible, reproducible, and predicts recovery.
Read the detailed description
Renal fibrosis is a final pathway and important biomarker of injury common to most forms of kidney disease. For example, in renal vascular disease (RVD) progressive renal fibrosis may induce kidney injury and hypertension. Early identification of fibrosis and adequate intervention may slow down renal disease progression, but adequate noninvasive strategies to detect and quantify renal fibrosis are yet to be identified.
Magnetization transfer imaging (MTI) magnetic resonance imaging (MRI) is a novel noninvasive method to evaluate the tissue macromolecular composition. The investigators have demonstrated that MTI can assess stenotic kidney fibrosis in murine and swine models of unilateral RVD. However, the clinical utility of MT-MRI to assess renal fibrosis is currently limited, because it is inherently semi-quantitative. In contrast, quantitative MT (qMT), based on biophysical compartment models, provides more objective measurement of tissue MT properties. A model fitting of MR signal acquired with various MT pulse amplitudes and offset frequencies, combined with scan-specific B0/B1/T1 maps, give rise to a more complete definition of tissue parameters, including a "bound pool fraction", a direct measure of the macromolecular content in tissue.
The hypothesis underlying this proposal is that qMT would reliably detect development of renal fibrosis at both 1.5 T and 3.0 T in subjects with RVD. To test this hypothesis, which is supported by strong preliminary data, the investigators will initially develop, optimize, and validate qMT for evaluation of fibrosis in the post-stenotic swine kidney. The investigators will correlate qMT-derived renal fibrosis with reference standards, as well as with single-kidney hemodynamics, function, and oxygenation, quantified using cutting-edge multi-detector CT (MDCT) and MRI techniques. The investigators will then determine the ability of qMT to predict renal recovery in pigs with RVD undergoing revascularization. Further, they will perform a pilot study to test the ability of qMT to quantify fibrosis in the post-stenotic human kidney, in comparison to innovative biomarkers of renal dysfunction and tissue damage.
Three specific aims will test the hypotheses: Specific Aim 1: qMT in stenotic swine kidneys is feasible, reliable, and reproducible at 1.5 and 3.0 T. Specific Aim 2: qMT predicts renal recovery potential in response to percutaneous transluminal renal angioplasty (PTRA). Specific Aim 3: qMT in stenotic human kidneys is feasible, reproducible, and predicts recovery.
The proposed studies may therefore establish a reliable, noninvasive, and clinically feasible strategy to quantify kidney fibrosis, a key biomarker for renal outcomes and therapeutic success.
- Conditions
- Hypertension, Renovascular
- Being tested
- qMT-MRI to detect fibrosis.
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qMT-MRI to detect fibrosis.Device
Also called CT scanning
The hypothesis underlying this proposal is that qMT would reliably detect development of renal fibrosis at both 1.5T and 3.0T in subjects with RVD. Patients will be studied with MRI (for fibrosis) and CT (for renal function).
| Study group | Role | What they receive |
|---|---|---|
| Early identification of fibrosis. | Other | A pilot study to test the ability of qMT to quantify fibrosis in the post-stenotic human kidney, in comparison to innovative biomarkers of renal dysfunction and tissue damage. We will pursue the Specific Aim that qMT in stenotic human kidneys is feasible and reproducible. Receives: Device: qMT-MRI to detect fibrosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrosis assessed by qMT-MRI in the stenotic kidney and contralateral kidneys
A significant difference in qMT bound pool fraction (f, %) in the stenotic compared to the contralateral kidney in RVD patients.
Measured: Baseline
Secondary outcomes (2)
Fibrosis assessed by qMT-MRI compared to stenotic kidney function
A significant correlation between qMT bound pool fraction (f, %) with function (SK-GFR) and oxygenation (SK-R2*) in the stenotic kidney.
Measured: Baseline
Fibrosis assessed by qMT-MRI compared to stenotic kidney injury markers
A significant correlation between qMT bound pool fraction (f, %) with levels of renal injury markers: Neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecular (KIM)-1, lactate dehydrogenase (LDH)], as well as urinary levels of extracellular vehicles (EVs) (measured by flow cytometry, %) originating from renal microvessels.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Oct 2020
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilach O Lerman, Mayo Clinic
- Investigators
- Lilach O Lerman, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508049
- Sponsor's protocol ID
- 19-008413
- Other IDs
- R01DK122734
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2020
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Al Saeedi M, Abdurakhimova DA, Arabi T, Nyvad J, Oudih M, Xing L, Lu B, Zhang L, Zhu X, Misra S, Lerman A, Lerman LO. Association between CT-evaluated Poststenotic Dilatation in Human Renal Artery Stenosis and Kidney Release of MCP-1. Radiology. 2026 Apr;319(1):e252637. doi: 10.1148/radiol.252637.
PubMed 42048594
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Magnetization Transfer MRI for Evaluation of Renal Fibrosis
- ClinicalTrials.gov ID
- NCT04508049
- Acronym / sponsor ID
- 19-008413
- Conditions
- Hypertension, Renovascular
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Aug 2020 (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.
The purpose of this study is to evaluate whether or not an MRI technique (quantitative magnetization transfer or qMT) in narrowing human kidneys is feasible, reproducible, and predicts recovery.
Detailed description
Renal fibrosis is a final pathway and important biomarker of injury common to most forms of kidney disease. For example, in renal vascular disease (RVD) progressive renal fibrosis may induce kidney injury and hypertension. Early identification of fibrosis and adequate intervention may slow down renal disease progression, but adequate noninvasive strategies to detect and quantify renal fibrosis are yet to be identified.
Magnetization transfer imaging (MTI) magnetic resonance imaging (MRI) is a novel noninvasive method to evaluate the tissue macromolecular composition. The investigators have demonstrated that MTI can assess stenotic kidney fibrosis in murine and swine models of unilateral RVD. However, the clinical utility of MT-MRI to assess renal fibrosis is currently limited, because it is inherently semi-quantitative. In contrast, quantitative MT (qMT), based on biophysical compartment models, provides more objective measurement of tissue MT properties. A model fitting of MR signal acquired with various MT pulse amplitudes and offset frequencies, combined with scan-specific B0/B1/T1 maps, give rise to a more complete definition of tissue parameters, including a "bound pool fraction", a direct measure of the macromolecular content in tissue.
The hypothesis underlying this proposal is that qMT would reliably detect development of renal fibrosis at both 1.5 T and 3.0 T in subjects with RVD. To test this hypothesis, which is supported by strong preliminary data, the investigators will initially develop, optimize, and validate qMT for evaluation of fibrosis in the post-stenotic swine kidney. The investigators will correlate qMT-derived renal fibrosis with reference standards, as well as with single-kidney hemodynamics, function, and oxygenation, quantified using cutting-edge multi-detector CT (MDCT) and MRI techniques. The investigators will then determine the ability of qMT to predict renal recovery in pigs with RVD undergoing revascularization. Further, they will perform a pilot study to test the ability of qMT to quantify fibrosis in the post-stenotic human kidney, in comparison to innovative biomarkers of renal dysfunction and tissue damage.
Three specific aims will test the hypotheses: Specific Aim 1: qMT in stenotic swine kidneys is feasible, reliable, and reproducible at 1.5 and 3.0 T. Specific Aim 2: qMT predicts renal recovery potential in response to percutaneous transluminal renal angioplasty (PTRA). Specific Aim 3: qMT in stenotic human kidneys is feasible, reproducible, and predicts recovery.
The proposed studies may therefore establish a reliable, noninvasive, and clinically feasible strategy to quantify kidney fibrosis, a key biomarker for renal outcomes and therapeutic success.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early identification of fibrosis. | Other | Device: qMT-MRI to detect fibrosis.A pilot study to test the ability of qMT to quantify fibrosis in the post-stenotic human kidney, in comparison to innovative biomarkers of renal dysfunction and tissue damage. We will pursue the Specific Aim that qMT in stenotic human kidneys is feasible and reproducible. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between ages 40 and 80 years old.
- Patients with hypertension (BP>140/90 mmHg) and/or requirement for two or more antihypertensive medications for more than 4 weeks.
- Serum creatinine under 2.2 and 2.0 mg/dL for men and women, respectively (Caucasians). Values for African-American subjects are slightly higher (2.4 mg/dL, males; 2.1 mg/dL females).
- No contraindications to angiography: severe contrast allergy.
- No contraindications to no-contrast MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia.
Key exclusion criteria (18 listed)
- Patient has serum creatinine >2.2 mg/dL for men and >2.0 mg/dL for women (Caucasians); >2.4 mg/dL for men and >2.1 mg/dL for women (African American).
- RVD in a solitary kidney
- Patients have clinically significant medical conditions within the prior six months: e.g. myocardial infarction, congestive heart failure, stroke, that would, in the opinion of the investigators, compromise the safety of the patient.
- Uncontrolled hypertension (Systolic BP >180 mmHg despite therapy).
- Diabetes requiring insulin or oral hypoglycemic medications.
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 |
|---|---|---|
| qMT-MRI to detect fibrosis.Also: CT scanningThe hypothesis underlying this proposal is that qMT would reliably detect development of renal fibrosis at both 1.5T and 3.0T in subjects with RVD. Patients will be studied with MRI (for fibrosis) and CT (for renal function). | Device | Early identification of fibrosis. |
Primary outcome
Fibrosis assessed by qMT-MRI in the stenotic kidney and contralateral kidneys
Time frame: Baseline
A significant difference in qMT bound pool fraction (f, %) in the stenotic compared to the contralateral kidney in RVD patients.
2 secondary outcomes
Fibrosis assessed by qMT-MRI compared to stenotic kidney function
Time frame: Baseline
Fibrosis assessed by qMT-MRI compared to stenotic kidney injury markers
Time frame: Baseline
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 16 Oct 2026.
- Derived from this study: PubMed 42048594Al Saeedi M, Abdurakhimova DA, Arabi T, Nyvad J, Oudih M, Xing L, Lu B, Zhang L, Zhu X, Misra S, Lerman A, Lerman LO. Association between CT-evaluated Poststenotic Dilatation in Human Renal Artery Stenosis and Kidney Release of MCP-1. Radiology. 2026 Apr;319(1):e252637. doi: 10.1148/radiol.252637.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lilach O Lerman, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing qMT-MRI to detect fibrosis. in people with Hypertension and Renovascular, run by Mayo Clinic at 1 site in United States.
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 7 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrosis assessed by qMT-MRI in the stenotic kidney and contralateral kidneys (time frame: Baseline). 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 NCT04508049, which also lists 1 linked publication.
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 16 Oct 2026.