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MRI for Renal Fibrosis Detection

N/A

Recruiting

Led By Lilach O Lerman, MD, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients are competent and able to provide written informed consent

Patients with hypertension (BP>140/90 mmHg) and/or requirement for two or more antihypertensive medications for more than 4 weeks

Must not have

RVD in a solitary kidney

Any active malignancy and undergoing therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether an MRI technique can accurately predict kidney function.

Who is the study for?

This trial is for adults aged 40-80 with high blood pressure needing multiple medications and normal kidney function (creatinine under specific levels). They must not have severe allergies to contrast agents, metal implants incompatible with MRI, claustrophobia, or conditions preventing protocol compliance. Excluded are those with recent serious medical events, uncontrolled hypertension, diabetes on medication, certain infections or drug requirements, heart issues, recent thrombosis, kidney transplant recipients or stones.

What is being tested?

The study tests if a special MRI technique called qMT can detect fibrosis in kidneys affected by narrowed arteries and predict recovery. It checks the method's feasibility and reliability in patients who meet specific health criteria.

What are the potential side effects?

Since this trial involves an imaging procedure rather than a drug intervention, side effects may include discomfort from lying still during the scan or reactions to any contrast material used if applicable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mentally capable of understanding and signing the consent form.

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I have high blood pressure or take two or more blood pressure medications.

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I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a single functioning kidney with reduced blood flow.

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I am currently receiving treatment for an active cancer.

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I need to take medication that might harm my kidneys.

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My high blood pressure is not controlled, even with medication.

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My heart's pumping ability is very low.

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I have a known kidney disease.

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I have had a kidney transplant.

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I cannot hold my breath for 20 seconds.

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I have a kidney or ureteric stone.

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I take insulin or pills to manage my diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fibrosis assessed by qMT-MRI in the stenotic kidney and contralateral kidneys

Secondary study objectives

Fibrosis assessed by qMT-MRI compared to stenotic kidney function

Fibrosis assessed by qMT-MRI compared to stenotic kidney injury markers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Early identification of fibrosis.Experimental Treatment1 Intervention

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.

0 / 13Eligibility criteria met