Evaluating kidney blood vessels in patients with ADPKD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Managing Depressive Symptoms in ADPKD: testing Digital Neurotherapy and Capacity Coaching

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• AZD1613 safety and how the body handles it in adults with ADPKD

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• Intravenous ABBV-CLS-628 for adults with autosomal dominant polycystic kidney disease

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• National Registry for Rare Kidney Diseases

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• Evaluating biomarkers in early autosomal dominant polycystic kidney disease

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.