Evaluating kidney blood vessels in patients with ADPKD
Noninvasive Evaluation of the Intrarenal Microvasculature in ADPKD
This study is testing a new ultrasound method to see if it can help us understand the blood vessels in the kidneys of people with Autosomal Dominant Polycystic Kidney Disease compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05288998 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the intrarenal microvasculature in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) using Super-resolution ultrasound (SRU). The study will compare the microvascular structure in ADPKD patients to that of healthy volunteers, focusing on the non-invasive evaluation of kidney function. By utilizing SRU, the researchers hope to overcome the limitations of current imaging techniques, which often involve invasive procedures or harmful agents. The findings could lead to improved early detection and monitoring of kidney disease progression.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 18-40 with a diagnosis of ADPKD and an estimated GFR greater than 70 mL/min/m2.
Not a fit: Patients with advanced stages of ADPKD or those with other systemic diseases affecting kidney function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for early detection and monitoring of kidney function in patients with ADPKD.
How similar studies have performed: While other imaging modalities have been explored, the use of Super-resolution ultrasound for this specific application in ADPKD is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (Patients with ADPKD): * Male and female subjects 18 - 40 years of age, inclusive * Previous diagnosis of ADPKD (based on Ravine et al. criteria) * Class 1 according to imaging classification * Estimated GFR\> 70 mL/min/m2 (CKD-Epi equation) * Ability to provide written, informed consent Inclusion Criteria (Healthy Volunteers): * Male and female subjects 18 - 40 years of age, inclusive * Estimated GFR\> 90 mL/min/m2 (CKD-Epi equation) * Ability to provide written, informed consent Exclusion Criteria (Patients with ADPKD): * Class 2 according to imaging classification * A concomitant systemic disease affecting the kidney (e.g., lupus, hepatitis B or C, amyloidosis) * Diabetes mellitus (fasting glucose \> 126 mg/dL or treatment with insulin or oral hypoglycemics). * Predicted urine protein excretion in urinalysis \>1 g/24 hrs. * Subjects having contraindications to or interference with MRI assessments. \[For example ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, large abdominal/back tattoos, etc.\]. * History of hypersensitivity allergic reactions to ultrasound contrast agents * High-risk cardiac disease (such as unstable hospital in-patients or ICU patients * Patients that are part of an interventional study or are taking tolvaptan * Female subjects that are pregnant Exclusion Criteria (Healthy Volunteers): * Family and/or personal history of kidney disease * Concomitant systemic disease that may affect the kidney * Diabetes mellitus * Predicted urine protein excretion in \>1 g/24 hrs, and or Abnormal urinalysis * Pregnant or lactating women * Subjects having contraindications to or interference with MRI assessments. \[For example ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, large abdominal/back tattoos, etc.\]. * History of hypersensitivity allergic reactions to ultrasound contrast agents * High risk cardiac disease (such as unstable hospital in-patients or ICU patients
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Maria V Irazabal, M.D., Ph.D — Mayo Clinic
- Study coordinator: Ahmed Abdelfattah
- Email: Abdelfattah.Ahmed@mayo.edu
- Phone: 507-284-2908
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.