Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate Renal Fibrosis Using MRI Techniques
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Hypertension
Renovascular
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief 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.
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 in...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04508049
Start Date
October 1 2020
End Date
December 1 2026
Last Update
October 14 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905