Intrarenal Microvasculature in ADPKD

Launched by MAYO CLINIC · Mar 11, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to see the tiny blood vessels inside the kidneys of people with Autosomal Dominant Polycystic Kidney Disease (ADPKD) using a special type of ultrasound called Super-resolution ultrasound (SRU). The goal is to understand how these blood vessels work in patients with ADPKD compared to healthy individuals. The study is currently recruiting participants aged 18 to 40, including those diagnosed with ADPKD and healthy volunteers.

To be eligible for the study, patients with ADPKD must have been diagnosed based on specific criteria and have good kidney function. Healthy volunteers should also have good kidney function and no history of kidney disease. Participants can expect to undergo non-invasive ultrasound tests, and they will need to provide written consent to join the study. It’s important to note that certain medical conditions, like diabetes or heart disease, and some factors, such as being pregnant, may prevent someone from participating. Overall, this trial aims to improve our understanding of kidney health in ADPKD, which could lead to better treatments in the future.

Gender

ALL

Eligibility 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